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Increlex Side Effects

Generic Name: mecasermin

Note: This document contains side effect information about mecasermin. Some of the dosage forms listed on this page may not apply to the brand name Increlex.

In Summary

Common side effects of Increlex include: tonsil disease. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to mecasermin: subcutaneous solution

Along with its needed effects, mecasermin (the active ingredient contained in Increlex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking mecasermin:

More Common

  • Anxiety
  • bluish skin color of the fingertips
  • blurred vision
  • breathlessness
  • chest pain
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • depression
  • dizziness
  • fast heartbeat
  • headache
  • increased hunger
  • loss of hearing
  • nausea
  • nervousness
  • nightmares
  • rapid growth of normal cells of the thymus (no symptoms)
  • seizures
  • shakiness
  • slurred speech
  • thickening of the skin
  • unusual tiredness or weakness

Incidence Not Known

  • Change in the ability to see colors, especially blue or yellow
  • cough
  • difficult or labored breathing
  • difficulty with swallowing
  • hives or welts
  • itching
  • itching or hives at the injection site
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • limp
  • pain in the hip or knee
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • shortness of breath
  • skin rash
  • tightness in the chest
  • vomiting
  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur while taking mecasermin:

Symptoms of Overdose

Some side effects of mecasermin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Abnormal response of the tympanic membrane to air pressure
  • difficulty with moving
  • difficulty with swallowing
  • ear pain
  • earache
  • large, flat, blue or purplish patches in the skin
  • muffled hearing
  • muscle pain or stiffness
  • redness or swelling in the ear
  • sense of fullness in the ear
  • snoring
  • sore throat
  • voice changing

For Healthcare Professionals

Applies to mecasermin: subcutaneous solution

General

The most common adverse events were hypoglycemia, injection site hypertrophy, snoring, hypoacusis, headache, and tonsillar hypertrophy.[Ref]

Metabolic

Very common (10% or more): Hypoglycemia (47%)

Common (1% to 10%): Hypoglycemic seizure, hyperglycemia, hyperlipidemia, obesity, increased weight[Ref]

Local

Very common (10% or more): Injection site hypertrophy (32%)

Common (1% to 10%): Injection site pain, injection site bruising, injection site fibrosis, injection site reaction, injection site swelling, injection site induration, injection site pigmentation changes

Postmarketing reports: Pruritus, urticaria, injection site reactions (e.g. erythema, pain, hematoma, hemorrhage, induration, rash, swelling)[Ref]

Other

Very common (10% or more): Hypoacusis (20%), febrile infection, otitis media, serous otitis media, chronic otitis media serous, otitis externa, ear infection

Common (1% to 10%): Fluid in middle ear, ear pain, abnormal tympanometry, ear tube insertion, otorrhea, ear disorder, middle ear disorder, tympanic membrane disorder, ear congestion, Mucosal membrane hyperplasia, hypertrophy, mucosal edema, asthenia, chest discomfort, abnormal tympanometry, adenotonsillectomy, adenoidectomy, ear tube insertion

Frequency not reported: Elevations in cholesterol, elevations in triglycerides[Ref]

Respiratory

Very common (10% or more): Snoring (22%), tonsillar hypertrophy (16%), upper respiratory tract infection, pharyngitis, tonsillitis

Common (1% to 10%): Tonsillectomy/adenoidectomy, obstructive sleep apnea, adenoidal hypertrophy, nasal turbinate hypertrophy, dyspnea, nasal mucosal disorder, obstructive airway disorder, abnormal respiration, nasal congestion, mouth breathing[Ref]

Nervous system

Very common (10% or more): Headache (18%)

Common (1% to 10%): Intracranial hypertension, dizziness, convulsions, febrile convulsion, benign intracranial hypertension, loss of consciousness, sleep apnea syndrome, dizziness, tremor, restless leg syndrome, lethargy[Ref]

Immunologic

Very common (10% or more): Anti-IGF-1 antibodies (up to 61%), thymus hypertrophy[Ref]

Cardiovascular

Common (1% to 10%): Cardiac murmur, cardiomegaly, ventricular hypertrophy, atrial hypertrophy, tachycardia, tachycardia paroxysmal, mitral valve incompetence, tricuspid valve incompetence, abnormal echocardiogram

Frequency not reported: Cardiomegaly/valvulopathy[Ref]

Gastrointestinal

Tonsillar hypertrophy appears to occur more frequently in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years.[Ref]

Very common (10% or more): Oral candidiasis

Common (1% to 10%): Vomiting, retching, abdominal pain, upper abdominal pain, abdominal distension, dysphagia[Ref]

Dermatologic

Common (1% to 10%): Lipohypertrophy, bruising, skin hypertrophy, acrochordons, abnormal hair texture, pigmented nevus

Frequency not reported: Thickening of the soft tissues of the face

Postmarketing reports: Alopecia, hair texture abnormal[Ref]

Hepatic

Common (1% to 10%): Increased alanine aminotransferase, increased aspartate aminotransferase

Frequency not reported: Elevated AST, elevated LDH, elevated ALT[Ref]

Hypersensitivity

Common (1% to 10%): Local and/or systemic hypersensitivity

Postmarketing reports: Anaphylaxis, local allergic reactions, generalized urticaria, angioedema, dyspnea[Ref]

Hematologic

Common (1% to 10%): Lymphadenopathy[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, pain in extremity, myalgia, scoliosis, spinal deformity, soft tissue disorder, muscle cramp, flank pain, musculoskeletal stiffness, congenital jaw malformation

Postmarketing reports: Osteonecrosis/avascular necrosis (occasionally associated with slipped capital femoral epiphysis)[Ref]

Renal

Common (1% to 10%): Nephrolithiasis, hydronephrosis, renal colic

Frequency not reported: Renal and splenic length increased rapidly[Ref]

Ocular

Common (1% to 10%): Papilledema, reduced visual acuity, myopia[Ref]

Genitourinary

Common (1% to 10%): Gynecomastia, ovarian cyst[Ref]

Psychiatric

Common (1% to 10%): Depression, sleep terror, nervousness, abnormal behavior, disorientation[Ref]

References

1. "Product Information. Increlex (mecasermin)." Tercica Inc, Brisbane, CA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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