temozolomide (Rx)

Brand and Other Names:Temodar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 5mg
  • 20mg
  • 100mg
  • 140mg
  • 180mg
  • 250mg

powder for injection

  • 100mg/vial

Anaplastic Astrocytoma

Indicated for the treatment of adults with refractory anaplastic astrocytoma (ie, patients with disease progression on a drug regimen containing nitrosourea and procarbazine)

Initial: 150 mg/m² PO/IV qDay for 5 days; repeat at 28-day cycles  

Maintenance: May increase/maintain dose at 200 mg/m² PO/IV qDay for 5 days/28-day cycle if ANC >1500 mm³ and platelets >100,000 mm³

Infuse IV over 90 minutes

Dosage modifications

  • Measure ANC and platelet on days 22 and 29 (day 1 of next cycle); modify dose for following cycle if:
  • ANC 1000-1500/mm³ or platelet 50,000-100,000/mm³: Postpone treatment until ANC >1500/mm³ and platelet >100,000/mm³; maintain initial dose
  • ANC <1000/mm³ or platelets <50,000/mm³
    • Postpone therapy until ANC >1,500/mm³ and platelets >100,000/mm³
    • Decrease dose by 50 mg/m²/day for subsequent cycles
    • Do NOT administer drug at dose <100 mg/m² for anaplastic astrocytoma

Decrease maintenance dose

  • Reduce from 200 mg/m²/day to 150 mg/m²/day and from 150 mg/m²/day to 100 mg/m²/day if
    • ANC <10,000/mm³
    • Platelets <50,000/mm²
    • CTC Grade 3 nonhematologic toxicity

Glioblastoma Multiforme

Indicated for the treatment of adults with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment

Initial: 75 mg/m² PO/IV qDay for 42 days concomitant with focal radiotherapy  

Infuse IV over 90 minutes

Continue treatment

  • Continue for up to 49 days if the criteria listed below are met
  • ANC ≥1,500/mm³, Platelet >100,000/mm³; CTC Grade 1 or lower

Dosage modifications (initial treatment and radiotherapy)

  • Interrupt if
    • ANC ≥500/mm³ but <1,500/mm³; CTC ≤Grade 1; resume when ANC ≥1,500/mm3
    • Platelets: ≥10,000/mm³ but ≤100,000/mm³; resume when platelet count ≥100,000/mm3
    • CTC Grade 2 nonhematologic toxicity; resume when resolution to ≤grade 1
  • Discontinue if
    • ANC <500/mm³
    • Platelets <10,000/mm³
    • CTC Grade 3 or 4 nonhematologic toxicity

Maintenance

  • Cycle 1 (Start 4 weeks AFTER temozolomide + radiotherapy): 150 mg/m² PO/IV qDay for 5 days, then 23-treatment free days
  • Cycle 2-6: may increase to 200 mg/m²/day if ANC >1500/mm³, platelets >100,000/mm³; CTC Grade <2

Orphan Designations

Newly diagnosed high grade glioma

  • Schering-Plough Research Institute; 2000 Galloping Hill Road; Kenilworth, NJ 07033

Advanced Metastatic Melanoma

  • Schering-Plough Research Institute; 2000 Galloping Hill Road; Kenilworth, NJ 0703

Nasopharyngeal carcinoma

  • NeOnc Technologies, Inc; 8335 Sunset Blvd., #240; Los Angeles, California 90069

Neuroblastoma

  • Orphelia Pharma; 85 Blvd Saint-Michel; Paris, France

Dosage Forms & Strengths

capsule

  • 5mg
  • 20mg
  • 100mg
  • 140mg
  • 180mg
  • 250mg

powder for injection

  • 100mg/vial

Glioblastoma Multiforme (Orphan)

Orphan designation for treatment of glioblastoma multiforme in pediatric patients

Sponsor

  • AmpliPharm Pharmaceuticals, LLC; 970 Peachtree Industrial Boulevard, Suite 100; Suwanee, Georgia 30024
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Interactions

Interaction Checker

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      Serious - Use Alternative

        Significant - Monitor Closely

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              Serious - Use Alternative (6)

              • adenovirus types 4 and 7 live, oral

                temozolomide decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • deferiprone

                deferiprone, temozolomide. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • influenza virus vaccine quadrivalent, adjuvanted

                temozolomide decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                temozolomide decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • palifermin

                palifermin increases toxicity of temozolomide by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • tofacitinib

                temozolomide, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (19)

              • acalabrutinib

                acalabrutinib, temozolomide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • belatacept

                belatacept and temozolomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • cholera vaccine

                temozolomide decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • dengue vaccine

                temozolomide decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • denosumab

                temozolomide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • fingolimod

                temozolomide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • hydroxyurea

                temozolomide, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • influenza A (H5N1) vaccine

                temozolomide decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • influenza virus vaccine (H5N1), adjuvanted

                temozolomide decreases effects of influenza virus vaccine (H5N1), adjuvanted by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • isavuconazonium sulfate

                temozolomide and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • meningococcal group B vaccine

                temozolomide decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • ofatumumab SC

                ofatumumab SC, temozolomide. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • olaparib

                temozolomide and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • ponesimod

                ponesimod and temozolomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • siponimod

                siponimod and temozolomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                temozolomide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • trastuzumab

                trastuzumab, temozolomide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, temozolomide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • valproic acid

                valproic acid increases levels of temozolomide by decreasing metabolism. Use Caution/Monitor. Cautions is advised.

              Minor (1)

              • food

                food decreases levels of temozolomide by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Absorption is affected by food and consistency of administration with respect to food is recommended.

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              Adverse Effects

              >10%

              Alopecia (55-69%)

              Lymphopenia (55%)

              Nausea (53%)

              Vomiting (42%)

              Headache (41%)

              Fatigue (34%)

              Constipation (33%)

              Anorexia (9-27%)

              Convulsions (23%)

              Thrombocytopenia (19%)

              Rash (8-19%)

              Hemiparesis (18%)

              Diarrhea (16%)

              Neutropenia (14%)

              Fever (13%)

              Asthenia (13%)

              Dizziness (12%)

              Peripheral edema (11%)

              Viral infections (11%)

              1-10% (selected)

              Amnesia (10%)

              Insomnia (10%)

              Abdominal pain (5-9%)

              Ataxia (8%)

              Back pain (8%)

              Paresis (8%)

              URI (8%)

              Urinary incontinence (8%)

              UTI (8%)

              Abnormal vision (5-8%)

              Pruritus (5-8%)

              Breast pain (6%)

              Depression (6%)

              Confusion (5%)

              Myalgia (5%)

              Weight gain (5%)

              Anemia (4%)

              Erythema (1%)

              Postmarketing Reports

              Alveolitis

              Interstitial pneumonitis

              Pulmonary fibrosis

              Hepatotoxicity including elevations of liver enzymes, hyperbillirubinemia, cholestasis, and hepatitis

              Diabetes insipidus

              Reactivation of infections including cytomegalovirus and hepatitis B

              Serious opportunistic infections, including some cases with fatal outcomes, can occur with bacterial, viral (primary and reactivated), fungal, and protozoan organisms

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              Warnings

              Contraindications

              Hypersensitivity to temozolomide, dacarbazine

              Cautions

              Myelosuppression reported, including prolonged pancytopenia, leukopenia, and anemia; may result in aplastic anemia, which in some cases has resulted in a fatal outcome; geriatric patients and women have higher risk of developing myelosuppression

              Severe hepatic/renal impairment, elderly

              Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, reported

              Prophylaxis for P. jiroveci pneumonia (pneumocystis pneumonia) required for all patients treated with temozolomide and radiation; risk increases with steroid therapy or longer treatment regimens

              Obtain CBC prior to treatment on Day 1 and on Day 22 (21 days after the first dose) of each cycle; perform weekly if ANC declines

              Fatal and severe hepatotoxicity reported; perform LFTs at baseline, midway through the first cycle, prior to each subsequent cycle, and ~2-4 weeks after the last dose

              Causes fetal harm when administered to pregnant women

              Prior to dosing, patients must have an ANC of 1.5 x 109/L or greater and a platelet count of 100 x 109/L or greater

              For concomitant phase with radiotherapy, obtain complete blood count prior to initiation of treatment and weekly during treatment

              All patients, particularly those receiving steroids, should be observed closely for the development of lymphopenia and PCP

              As bioequivalence has been established only when given over 90 minutes, infusion over a shorter or longer period of time may result in suboptimal dosing; the possibility of an increase in infusion-related adverse reactions cannot be ruled out

              For patients with newly diagnosed glioblastoma, provide PCP prophylaxis for all patients during concomitant phase; continue in patients who experience lymphopenia until resolution to grade 1 or less

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              Pregnancy & Lactation

              Pregnancy

              Based on mechanism of action and findings from animal studies, therapy can cause fetal harm when administered to a pregnant woman; available postmarketing reports describe cases of spontaneous abortions and congenital malformations, including polymalformations with central nervous system, facial, cardiac, skeletal, and genitourinary system anomalies with exposure to drug during pregnancy; these cases report similar adverse developmental outcomes to those observed in animal studies

              Verify pregnancy status in females of reproductive potential prior to initiating therapy

              Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after last dose

              Because of potential for embryofetal toxicity and genotoxic effects on sperm cells, advise male patients with pregnant partners or female partners of reproductive potential to use condoms during treatment and for at least 3 months after final dose

              Advise male patients not to donate semen during treatment and for at least 3 months after final dose

              Therapy may impair male fertility; limited data from male patients show changes in sperm parameters during treatment; however, no information is available on duration or reversibility of these changes

              Animal data

              • Administration of drug to rats and rabbits during period of organogenesis caused numerous external, internal, and skeletal malformations at doses less than maximum human dose based on body surface area; advise pregnant women of potential risk to fetus

              Lactation

              There are no data on presence of drug or its metabolites in human milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions, including myelosuppression from temozolomide in breastfed children, advise women not to breastfeed during treatment and for at least 1 week after final dose

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Imidazotetrazine derivative prodrug; active metabolite MTIC methylates guanine-rich areas of DNA that initiate transcription, which lead to DNA double strand breaks and apoptosis

              Absorption

              Rapidly and completely absorbed after oral administration

              Peak plasma time: 1 hr (empty stomach); 2.25 hr (high-fat meal)

              Bioequivalence: 100%; IV infusion (when administered over 90 min) is bioequivalent to same dose of oral capsule

              Mean peak plasma concentration and AUC decreased by 32% and 9%, respectively when administered after a high-fat breakfast

              Distribution

              Protein bound: 15%

              Vd: 0.4 L/kg

              Metabolism

              Metabolite: Hydrolyzed at physiologic pH to 3-methyl-(triazen-1-yl) imidazole-4-carboxamide (MTIC); MTIC further hydrolyzed to to 5-amino-imidazole-4-carboxamide (AIC), which is known to be an intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species

              Elimination

              Half-life: 1.8 hr

              Clearance: 5.5 L/hr/m²

              Excretion: primarily urine (~38%)

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              Administration

              IV Preparation

              Bring the vial to room temp

              Reconstitute 100-mg vial with 41 mL SWI to obtain 2.5 mg/mL solution; gently swirl to dissolve (do not shake)

              After reconstitution, store at room temp and use within 14 hr, including infusion time

              Using aseptic technique, withdraw up to 40 mL per vial to get required dose and transfer into empty 250 mL PVC infusion bag

              IV Administration

              Infuse IV using pump over 90 min

              Flush lines before and after infusion

              Do not infuse other medications simultaneously thru same infusion line

              Oral Administration

              Take capsule consistently either with or without food; preferably take on empty stomach HS to avoid N/V

              May consider antiemetics before/after

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Temodar intravenous
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              100 mg vial
              Temodar oral
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              250 mg capsule
              Temodar oral
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              100 mg capsule
              Temodar oral
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              180 mg capsule
              Temodar oral
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              140 mg capsule
              Temodar oral
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              20 mg capsule
              Temodar oral
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              5 mg capsule
              temozolomide oral
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              180 mg capsule
              temozolomide oral
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              140 mg capsule
              temozolomide oral
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              5 mg capsule
              temozolomide oral
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              250 mg capsule
              temozolomide oral
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              180 mg capsule
              temozolomide oral
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              100 mg capsule
              temozolomide oral
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              20 mg capsule
              temozolomide oral
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              5 mg capsule
              temozolomide oral
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              140 mg capsule
              temozolomide oral
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              5 mg capsule
              temozolomide oral
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              20 mg capsule
              temozolomide oral
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              100 mg capsule
              temozolomide oral
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              250 mg capsule
              temozolomide oral
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              180 mg capsule
              temozolomide oral
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              250 mg capsule
              temozolomide oral
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              20 mg capsule
              temozolomide oral
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              100 mg capsule
              temozolomide oral
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              250 mg capsule
              temozolomide oral
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              5 mg capsule
              temozolomide oral
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              140 mg capsule
              temozolomide oral
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              180 mg capsule
              temozolomide oral
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              140 mg capsule
              temozolomide oral
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              100 mg capsule
              temozolomide oral
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              5 mg capsule
              temozolomide oral
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              20 mg capsule
              temozolomide oral
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              100 mg capsule
              temozolomide oral
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              140 mg capsule
              temozolomide oral
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              180 mg capsule
              temozolomide oral
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              250 mg capsule
              temozolomide oral
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              180 mg capsule
              temozolomide oral
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              100 mg capsule
              temozolomide oral
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              20 mg capsule
              temozolomide oral
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              5 mg capsule
              temozolomide oral
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              100 mg capsule
              temozolomide oral
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              250 mg capsule
              temozolomide oral
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              140 mg capsule
              temozolomide oral
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              180 mg capsule
              temozolomide oral
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              140 mg capsule
              temozolomide oral
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              250 mg capsule
              temozolomide oral
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              100 mg capsule
              temozolomide oral
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              20 mg capsule
              temozolomide oral
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              5 mg capsule
              temozolomide oral
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              250 mg capsule
              temozolomide oral
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              250 mg capsule

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

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              temozolomide intravenous

              TEMOZOLOMIDE - INJECTION

              (TEM-oh-ZOL-oh-mide)

              COMMON BRAND NAME(S): Temodar

              USES: This medication is used to treat certain types of brain cancer. Temozolomide belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using temozolomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein as directed by your doctor. It is given by a health care professional, usually over 90 minutes.The dosage and treatment schedule are based on your medical condition, height, weight, and response to treatment. To get the most benefit, carefully follow the dosing schedule as directed by your doctor. To help you remember, mark your calendar to keep track of when to receive the next dose.Your doctor may also prescribe other medications (such as antibiotics) to help prevent infection or side effects. Follow your doctor's directions for taking all your medications.

              SIDE EFFECTS: Nausea, vomiting, loss of appetite, mouth sores, changes in taste, constipation, tiredness, dizziness, trouble sleeping, headache, or pain/redness/swelling at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Although temozolomide is used to treat cancer, it may rarely increase your risk of getting other cancers. Also, temozolomide decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.Tell your doctor right away if you have any serious side effects, such as: symptoms of liver damage (such as stomach/abdominal pain, yellowing eyes/skin, dark urine).Get medical help right away if you have any very serious side effects, such as: seizure.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before receiving temozolomide, tell your doctor or pharmacist if you are allergic to it; or to dacarbazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, bleeding/blood problems.Temozolomide can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products).Women and older adults may be more sensitive to the side effects of this drug, especially increased risk of infection and easy bruising/bleeding.Men should not donate sperm while using temozolomide and for 3 months after stopping this drug.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using temozolomide. Temozolomide may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after stopping treatment. Men using this medication who have a partner that is pregnant or who can become pregnant should use a condom for birth control during treatment and for 3 months after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for at least 1 week after stopping treatment. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: nalidixic acid.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Lab and/or medical tests (such as complete blood count, liver function, brain scan) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

              STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.