Increlex

mecasermin

(me-ca-ser-min) ,

Increlex

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: growth hormones
Pregnancy Category: C

Indications

Long-term treatment of growth failure in children due to primary insulin-like growth factor-1 (IGF) deficiency or growth hormone gene deletion with antibodies to growth hormone.

Action

Under normal conditions, growth hormone attaches to receptors resulting in increased production of IGF-1. IGF-1 stimulates uptake of glucose, fatty acids and amino acids which support tissue growth. These processes signal and support statural growth.

Therapeutic effects

Replacement of IGF-1 in deficiency states resulting in achievement of optimal potential statural growth.

Pharmacokinetics

Absorption: Well absorbed following subcutaneous administration.
Distribution: Bound to various binding proteins.
Metabolism and Excretion: Some metabolism in liver and kidney.
Half-life: 5.8 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
subcutrapid3 hr12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Pediatric: Contains benzyl alcohol, avoid in neonates; Closed epiphyses; Active/suspected neoplasia.
Use Cautiously in: Adults (safety not established); Pediatric: Children <2 yr (safety not established); Obstetric / Lactation: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • dizziness
  • headache
  • intracranial hypertension

Respiratory

  • tonsillar hypertrophy (most frequent)
  • snoring

Gastrointestinal

  • vomiting

Endocrinologic

  • hypoglycemia (life-threatening)

Local

  • bruising
  • lipohypertrophy

Musculoskeletal

  • arthralgia
  • extremity pain

Miscellaneous

  • anaphylaxis (life-threatening)
  • hypersensitivity reactions (life-threatening)
  • thymus hypertrophy

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Subcutaneous (Children) 0.04–0.08 mg/kg twice daily; may be ↑ weekly by 0.04 mg/kg/dose up to 0.12 mg/kg twice daily.

Availability

Solution for injection: 10 mg/mL

Nursing implications

Nursing assessment

  • Monitor bone age annually and growth rate determinations, height, and weight every 3–6 mo during therapy.
  • Assess tonsils for hypertrophy periodically during therapy. Signs may include (snoring, difficulty breathing or swallowing, sleep apnea, fluid in the middle ear).
  • To assess for intracranial hypertension, fundoscopic examinations are recommended prior to and periodically during therapy. May cause headache with nausea and vomiting.
  • Monitor patient for allergic reactions (rash, hives, angioedema, pruritus, urticaria, difficulty breathing). May require interruption of therapy.
  • Monitor patients for thickening of soft tissues of the face periodically during therapy.
  • Lab Test Considerations: Monitor preprandial glucose levels during therapy.
    • May cause mild ↑ in serum AST, ALT, and LDH.

Potential Nursing Diagnoses

Disturbed body image (Indications)

Implementation

  • Administer within 20 min of a meal or snack; may have insulin-like hypoglycemic effects. Do not administer if meal or snack is omitted. If a dose is omitted, do not increase dose to make up for missed doses.
    • Therapy should be initiated at a low dose and not increased until no hypoglycemic episodes have occurred for at least 7 day. If sever hypoglycemia occurs despite adequate food intake, consider dose reduction.
    • If using syringes measuring dose in units, convert doses in mg/kg to units using formula: Weight (kg) x Dose (mg/kg) x 1 mL/10 mg x 100 units/1 mL = units/injection.
  • Subcutaneous: Administer twice daily in upper arm, thigh, abdomen, or buttocks. Rotate sites with each injection. Solution is clear; do not administer solution that is cloudy or contains a precipitate. Solution is stable for 30 days after opening vial if refrigerated. Keep vial away from direct heat and bright light. Discard unused solution.

Patient/Family Teaching

  • Instruct patients and/or their parents how to administer mecasermin, injection technique, and equipment disposal. Advise patient and/or parents to read Patient Information package insert before starting therapy and with each prescription refill in case of changes.
  • Advise patient and parents not to give mecasermin to any other person; may be harmful.
  • Discuss the importance of a well-balanced diet including protein and fat such as meat and cheese. Advise parents to monitor for signs of hypoglycemia (dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea, fast or irregular heartbeat). Severe hypoglycemia may result in unconsciousness, seizures, and death. A source of sugar such as orange juice, glucose gel, candy, or milk should be available at all times.
  • Caution patients to avoid driving and other activities requiring alertness until response to medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise parent to notify health care professional if signs of tonsillar hypertrophy, increased intracranial pressure, or allergic reaction occur.

Evaluation/Desired Outcomes

  • Increase in statural growth.

Increlex

a trademark for mecasermin.
Mentioned in ?
References in periodicals archive ?
For the last nine months, his parents have given him Increlex injections, twice a day, every day.
s growth-factor treatment Increlex is scheduled to move from Baltimore to Hopkinton.
Title: Increlex Launch Ad Agency: DPM Advertising Creative Director: Jay Doniger Art Director: Melanie Fiacchino Copywriter: Jim Ardito Account Managers: Shana Robinson, Karen Sun Photographer: Laurie Rubin Product Manager: Susan Billat Client: Tercica
Increlex was launched as a new drug for children with growth failure with severe primary IGF-1 deficiency.
The company's first product candidate, Increlex (mecasermin (rDNA origin) injection), or recombinant human insulin-like growth factor-1 (rhIGF-1), is being developed for the treatment of short stature and associated metabolic disorders.
The three-year pilot study will randomize 40 girls (aged 2 to 12) with Rett syndrome to receive the drug, known as Increlex (Tercica Inc.
s Increlex, long-term treatment for growth failure in children with severe primary IGF-1 deficiency; and Insmed's IPLEX, a treatment for growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion.
Except for the historical statements contained herein, this press release contains forward-looking statements that are subject to risks and uncertainties, including the statement about the ultimate safety and efficacy profile of Increlex.
We remain very confident in the quality of the investigators and data contained in our NDA, in the thoughtful manner in which the FDA has interacted with us during the last several years, and in the ultimate safety and efficacy profile of Increlex when it is used to treat patients with severe Primary IGF-1 deficiency," said Dr.
Increlex([R]) - For the first quarter 2009, Increlex sales reached [euro]4.
Results also were presented from a pharmacokinetic study comparing once-daily dosing versus twice-daily dosing of Increlex in children with Primary IGFD as well as results of a comparative study of four IGF-1 assay systems for the biochemical detection or diagnosis of IGF-1 deficiency.
The FDA also designated Increlex as an orphan drug for severe Primary IGFD.