Mecasermin

Mecasermin is used 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.

Mecasermin is available under the following different brand names: Increlex.

Dosages of Mecasermin:

Dosage Forms and Strengths

Injectable Solution

• 10mg/mL

Dosage Considerations – Should be Given as Follows:

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
• Children under 2 years: Safety and efficacy not established
• Children 2 years and older: 40-80 mcg/kg subcutaneously (SC) every 12 hours, may increase after 1 week by 40 mcg/kg/dose, not to exceed 120 mcg/kg SC every 12 hours

Common side effects of mecasermin include:

• Low blood sugar (hypoglycemia)
• Tonsil enlargement
• Cardiac murmur
• Dizziness
• Convulsions
• Headache
• Fatty lumps
• Thymus gland enlargement
• Joint pain
• Ear problems
• Middle ear infection (otitis media)

Less common side effects of mecasermin include:

• Anaphylaxis
• Generalized hives
• Angioedema
• Shortness of breath
• Local allergic reactions at the injection site (e.g., itching, hives)
• Hair loss, abnormal hair texture

Postmarketing side effects of mecasermin reported include:

• Systemic hypersensitivity: anaphylaxis, generalized hives, angioedema, shortness of breath
• Local allergic reactions at the injection site: itching, hives
• Skin and Subcutaneous Tissue Disorders: alopecia, hair texture abnormal
• General disorders and administrative site conditions: Injection site reactions (e.g., redness, pain, bruising, 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)

Less common side effects of mecasermin include:

• Neurotoxicity
• Kidney toxicity
• Acute respiratory failure (inhalation route)
• Respiratory tract paralysis

Other side effects of mecasermin include:

• Slurred speech
• Spinning sensation (vertigo)
• Seizures
• Severe allergic reaction (anaphylaxis)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Mecasermin has no listed severe interactions with other drugs.
• Serious interactions of mecasermin include:
  • macimorelin
• Mecasermin has moderate with at least 26 different drugs.
• Mecasermin has no listed mild interactions with other drugs.

Warnings

• This medication contains mecasermin. Do not take Increlex if you are allergic to mecasermin or any ingredients contained in this drug.

Contraindications

• Hypersensitivity to product or components
• Closed epiphyses
• Active or suspected neoplasia; discontinue if neoplasia develops
• Intravenous (IV) administration
• Pediatric patients with malignant neoplasia or a history of malignancy

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Mecasermin?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Mecasermin?"

Cautions

• Do not give without meal/snack 20 min before/after (risk of hypoglycemia)
• Not a substitute for GH treatment
• Contains benzyl alcohol as a 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 before therapy
• Evaluate any child with the onset of a limp or hip/knee pain for possible slipped capital femoral epiphysis
• Patients should avoid engaging in high-risk activities (e.g., 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 the relationship between therapy and new occurrence of neoplasia; monitor all patients receiving therapy carefully for the development of neoplasms; advise patients/caregivers to report the development of new neoplasms; if malignant neoplasia develops, discontinue treatment

Pregnancy and Lactation

• There are no available data on the use of mecasermin in pregnant women. Exposure during pregnancy is unlikely because mecasermin is not indicated for use after epiphyseal closure.
• There is no information available on the presence of mecasermin in human or animal milk, its effects on breastfed infants, or milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on a breastfed child from mecasermin treatment or the underlying maternal condition.