mecasermin (Rx)

  • Print
Brand and Other Names:Increlex

Dosing & Uses

AdultPediatric

Not indicated for adult use

Dosage Forms & Strengths

injectable solution

  • 10mg/mL
more...

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

Increlex: 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
Next:

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 
            Previous
            Next:

            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

            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)

            Previous
            Next:

            Warnings

            Contraindications

            Hypersensitivity to product or components

            Closed epiphyses

            Active or suspected neoplasia; discontinue if neoplasia develops

            IV administration

            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

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not known whether excreted in breast milk, use caution

            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.

            more...
            Previous
            Next:

            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

            Previous
            Next:

            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

            Previous
            Next:

            Images

            Previous
            Next:

            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.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous