mecasermin (Rx)

Brand and Other Names:Increlex
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Dosing & Uses

AdultPediatric

Not indicated for adult use

Dosage Forms & Strengths

injectable solution

  • 10mg/mL

Growth Failure

Indicated for long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH

<2 years: Safety and efficacy not established

≥2 years: 40-80 mcg/kg SC q12hr, may increase after 1 week by 40 mcg/kg/dose, not to exceed 120 mcg/kg SC q12hr  

Rett Syndrome (Orphan)

Orphan designation for treatment of Rett syndrome

Sponsor

  • Keck Graduate Institute of Applied Life Sciences; 535 Watson Drive; Claremont, California 91711
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Interactions

Interaction Checker

and mecasermin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • macimorelin

                mecasermin, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that may blunt the growth hormone (GH) response to macrimorelin may impact the accuracy of the diagnostic test. Discontinue GH products at least 1 week before administering macimorelin.

              Monitor Closely (26)

              • acarbose

                mecasermin increases effects of acarbose by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • chlorpropamide

                mecasermin increases effects of chlorpropamide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • glimepiride

                mecasermin increases effects of glimepiride by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • glipizide

                mecasermin increases effects of glipizide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • glyburide

                mecasermin increases effects of glyburide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • insulin aspart

                mecasermin increases effects of insulin aspart by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • insulin degludec

                mecasermin, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.

              • insulin degludec/insulin aspart

                mecasermin, insulin degludec/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.

              • insulin detemir

                mecasermin increases effects of insulin detemir by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • insulin glargine

                mecasermin increases effects of insulin glargine by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • insulin glulisine

                mecasermin increases effects of insulin glulisine by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • insulin inhaled

                mecasermin, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.

              • insulin lispro

                mecasermin increases effects of insulin lispro by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • insulin NPH

                mecasermin increases effects of insulin NPH by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • insulin regular human

                mecasermin increases effects of insulin regular human by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • metformin

                mecasermin increases effects of metformin by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • miglitol

                mecasermin increases effects of miglitol by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • nateglinide

                mecasermin increases effects of nateglinide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • pioglitazone

                mecasermin increases effects of pioglitazone by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • repaglinide

                mecasermin increases effects of repaglinide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • rosiglitazone

                mecasermin increases effects of rosiglitazone by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • saxagliptin

                mecasermin increases effects of saxagliptin by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • sitagliptin

                mecasermin increases effects of sitagliptin by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • tolazamide

                mecasermin increases effects of tolazamide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • tolbutamide

                mecasermin increases effects of tolbutamide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              • vildagliptin

                mecasermin increases effects of vildagliptin by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.

              Minor (0)

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                Adverse Effects

                >10%

                Hypoglycemia (42%)

                Tonsillar hypertrophy (15%)

                1-10%

                Cardiac murmur (>5%)

                Dizziness (>5%)

                Convulsion (>5%)

                Headache (>5%)

                Lipohypertrophy (>5%)

                Thymus hypertrophy (>5%)

                Arthralgia (>5%)

                Ear problems (>5%)

                Otitis media (>5%)

                <1%

                Anaphylaxis

                Generalized urticaria

                Angioedema

                Dyspnea

                Local allergic reactions at the injection site (eg, pruritus, urticaria)

                Alopecia, hair texture abnormal

                Postmarketing Reports

                Systemic hypersensitivity: anaphylaxis, generalized urticaria, angioedema, dyspnea

                Local allergic reactions at the injection site: pruritus, urticaria

                Skin and Subcutaneous Tissue Disorders: alopecia, hair texture abnormal

                General disorders and administrative site conditions: Injection site reactions (eg, erythema, pain, hematoma, hemorrhage, induration, rash, swelling)

                Musculoskeletal and connective tissue disorders: Osteonecrosis/avascular necrosis (occasionally associated with slipped capital femoral epiphysis)

                Neoplasms Benign, Malignant and Unspecified (including cysts and polyps)

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                Warnings

                Contraindications

                Hypersensitivity to product or components

                Closed epiphyses

                Active or suspected neoplasia; discontinue if neoplasia develops

                IV administration

                Pediatric patients with malignant neoplasia or a history of malignancy

                Cautions

                Do not give without meal/snack 20 min before/after (risk of hypoglycemia)

                Not a substitute for GH treatment

                Contains benzyl alcohol as preservative (associated with fatal "Gasping Syndrome" in preemies)

                Possibility of thickening of facial soft tissues

                Allergic reactions reported include localized (injection site) reactions to severe systemic reactions, including anaphylaxis requiring hospitalization

                Symptoms associated with intracranial hypertension including nausea, headache, papilledema, vomiting, visual changes reported; funduscopic examinations are recommended

                Lymphoid hypertrophy that may lead to complications such as chronic middle ear effusions, snoring, and sleep apnea reported

                Children experiencing rapid growth may have progression of scoliosis

                Caution in patients at risk for diabetes or patients being treated for diabetes

                Treat thyroid deficiency prior to therapy

                Evaluate any child with onset of a limp or hip/knee pain for possible slipped capital femoral epiphysis

                Patients should avoid engaging in high-risk activities (eg, driving, exercise, etc.) within 2 to 3 hours after dosing, particularly during initiation of treatment until tolerability and stable dose established

                There have been postmarketing reports of malignant neoplasms in pediatric patients who have received treatment; unknown whether there is relationship between therapy and new occurrence of neoplasia; monitor all patients receiving therapy carefully for development of neoplasms; advise patients/caregivers to report development of new neoplasms; if malignant neoplasia develops, discontinue treatment

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                Pregnancy & Lactation

                Pregnancy

                There are no available data on use in pregnant women; exposure during pregnancy is unlikely because the drug is not indicated for use after epiphyseal closure

                Animal data

                • In animal reproduction studies, there were no observed embryo-fetal development abnormalities with intravenous administration to pregnant rats and rabbits during fetal organogenesis given at exposures up to 11 and 3 times maximum recommended human dose (MRHD) of 0.24 mg/kg/day based on body surface area (BSA), respectively

                Lactation

                There is no information available on presence of mecasermin in human or animal milk, effects on breastfed infant, or on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breast-fed child from treatment or from underlying maternal condition

                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

                Recombinant human IGF-1 used as replacement therapy in patients primary severe IGF-I deficiency, growth hormone receptors in the liver that are unresponsive to GH

                Pharmacokinetics

                Metabolism: Liver, kidney

                Half-Life: 5.8 hr (mecasermin); >12 hr (mecasermin rinfabate)

                Excretion: Likely as native proteins

                Vd: 0.184-0.33 L/kg

                Protein binding: 80% bound to IFGBP-3 and an acid-labile subunit

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                Administration

                SC Injection

                Give shortly before/after meal or snack (~20 minutes) to avoid hypoglycemia

                If hypoglycemia occurs with recommended doses despite adequate food intake, the dose should be reduced

                Rotate injection site to avoid lipodystrophy

                Storage

                Refrigerate unopened vials; after opening, vial contents are stable for 30 days when refrigerated

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                Images

                No images available for this drug.
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                Patient Handout

                Patient Education
                mecasermin subcutaneous

                NO MONOGRAPH AVAILABLE AT THIS TIME

                USES: Consult your pharmacist.

                HOW TO USE: Consult your pharmacist.

                SIDE EFFECTS: Consult your 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: Consult your pharmacist.

                DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

                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: No monograph available at this time.

                MISSED DOSE: Consult your pharmacist.

                STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

                Information last revised July 2016. 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.