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.
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References in periodicals archive ?
(later sold to the Ipsen Group), where he was instrumental in the commercial launch of Dysport (abobotulinumtoxinA) and Increlex (mecasermin rDNA origin injection).
M2 EQUITYBITES-October 2, 2015-Ipsen to release additional batch of Increlex in US commercially
M2 PHARMA-October 2, 2015-Ipsen to release additional batch of Increlex in US commercially
Mecasermin (Trade name INCRELEX) is the synthetic form of the protein which is used as an effective treatment for particular disorders such as short stature, type 1 and 2 diabetes, and wound healing.
Production of Tercica Inc.'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
In August, the agency approved Increlex (mecasermin [rDNA origin] injection, Tercica Inc.).
In August 2005, the agency approved Increlex (mecasermin [rDNA origin] injection, Tercica Inc.).
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.
M2 PHARMA-May 13, 2014-Ipsen to renew supply of Increlex in the US
M2 EQUITYBITES-May 13, 2014-Ipsen to renew supply of Increlex in the US
The Food and Drug Administration approved Increlex for long-term treatment of growth failure in children 2 years or older with severe primary insulinlike growth factor-1 (IGF-1) deficiency or with growth hormone gene deletion.