Mecasermin

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

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

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

If you inject too much mecasermin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If mecasermin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Mecasermin is a man-made form of insulin-like growth factor-1 (IGF-1), a substance that is normally produced in the body. IGF-1 is important for the growth of bones and muscles.

Mecasermin is used to treat growth failure in children whose bodies do not make enough IGF-1.

Mecasermin is not for use in children who have growth hormone deficiency, malnutrition, underactive thyroid, or those who are taking long-term steroid medications.

Mecasermin may also be used for purposes not listed in this medication guide.

Other drugs may interact with mecasermin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines your child uses now and any medicine the child starts or stops using.

Somatotropin agonist (a somatomedin); biosynthetic (recombinant DNA origin) form of human insulin-like growth factor I (IGF-1; IGF-I).1 8 21

Insulin-Like Growth Factor I Deficiency

Long-term replacement therapy for treatment of growth failure in children with severe primary insulin-like growth factor I (IGF-I) deficiency (primary IGFD) or growth hormone (GH) gene deletion.1 3 13 25

Designated an orphan drug by FDA for the treatment of GH insensitivity syndrome4 11 (i.e., various genetic and acquired conditions with action of GH absent or attenuated).3

Mecasermin rinfabate (Iplex) previously was approved for treatment of growth failure in children with IGF-I deficiency or GH deletion,22 but no longer is commercially available after litigation regarding patent infringement.23 24 28 (See Amyotrophic Lateral Sclerosis under Uses.)

Patients with severe primary IGFD have extremely short stature (defined as height standard deviation score not exceeding -3), low serum concentrations of IGF-I (defined as standard deviation score not exceeding -3), and normal or elevated GH secretion.1 3 7 25 Primary IGFD may be associated with abnormalities of the GH receptor, post-GH-receptor signaling pathway, or the IGF-I gene resulting in GH insensitivity;1 2 25 exogenously administered GH not expected to elicit an adequate response in these patients.1 3 25

Patients with GH gene deletion are likely to develop GH-neutralizing antibodies following exposure to exogenous GH preparations (secondary GH insensitivity syndrome, isolated GH deficiency type IA).1 3 13 21

Not intended for use in children with secondary forms of IGF-I deficiency (e.g., GH deficiency [not including those with GH gene deletion], malnutrition, hypothyroidism, corticosteroid-induced growth failure).1 21 25 Correct thyroid and nutritional deficiencies prior to initiation of mecasermin therapy.1 Not a substitute for GH therapy.1

Safety and efficacy not established in adults.1

Amyotrophic Lateral Sclerosis

Mecasermin rinfabate (Iplex), a combination of IGF-I and IGF binding protein-3, has been used in the management of amyotrophic lateral sclerosis† in a limited number of patients.26 27 29

Currently available under a limited-access investigational new drug (IND) protocol.28

Limited evidence with the drug suggests a slower rate of progression of amyotrophic lateral sclerosis, but such findings remain to be confirmed.26 27 29

Primary insulin-like growth factor-1 deficiency: Treatment of growth failure in children with severe primary insulin-like growth factor 1 (IGF-1) deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dizziness, vomiting, or joint pain. Have caregiver report immediately to prescriber signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating), severe headache, vision changes, eye pain, severe eye irritation, snoring, sleep apnea, enlarged tonsils, ear pain, severe nausea, severe vomiting, hip or knee pain, limp, or seizures (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.