Increlex Side Effects

Generic Name: Mecasermin

Please note - some side effects for Increlex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Increlex - for the consumer

Increlex

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Increlex:

Dizziness; headache; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in heart rhythm; convulsions; dizziness; ear pain or infections; enlarged glands in neck or chest; headache; hearing problems; increased pressure in the brain; joint pain; low blood sugar (changes in vision, chills, dizziness, drowsiness, fainting, headache, increased heartbeat, increased hunger, nervousness, sweating, tremor, weakness); lumps or bruising at the injection site; nausea; pain in arms or legs; sleep apnea; snoring; swelling in the eye; tonsil enlargement; vision changes; vomiting.

For the professional

Increlex

As with all protein pharmaceuticals, some patients may develop antibodies to Increlex™. Anti-IGF-1 antibodies were present at one or more of the periodic assessments in 14 of 23 children with Primary IGFD treated for 2 years. However, no clinical consequences of these antibodies were observed (e.g., allergic reactions or attenuation of growth).

In clinical studies of 71 subjects with Primary IGFD treated for a mean duration of 3.9 years and representing 274 subject-years, no subjects withdrew from any clinical study because of adverse events. Adverse events considered related to Increlex™ treatment that occurred in 5% or more of these study participants are listed below by organ class.

Metabolism and Nutrition Disorders: hypoglycemia

General Disorders and Administrative Site Conditions: lipohypertrophy, bruising

Infections and Infestations: otitis media, serous otitis media

Respiratory, Thoracic and Mediastinal Disorders: snoring, tonsillar hypertrophy

Nervous System Disorders: headache, dizziness, convulsions

Gastrointestinal Disorders: vomiting

Ear and Labyrinth Disorders: hypoacusis, fluid in middle ear, ear pain, abnormal tympanometry

Cardiac Disorders: cardiac murmur

Musculoskeletal and Connective Tissue Disorders: arthralgia, pain in extremity

Blood and Lymphatic System Disorders: thymus hypertrophy

Surgical and Medical Procedures: ear tube insertion

Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy. Most cases of hypoglycemia were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion and 4 subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion. Of the 30 subjects reporting hypoglycemia, 14 (47%) had a history of hypoglycemia prior to treatment. The frequency of hypoglycemia was highest in the first month of treatment, and episodes were more frequent in younger children. Symptomatic hypoglycemia was generally avoided when a meal or snack was consumed either shortly (i.e., 20 minutes) before or after the administration of Increlex™.

Tonsillar hypertrophy was noted in 11 (15%) subjects in the first 1 to 2 years of therapy with lesser  tonsillar growth in subsequent years. Tonsillectomy or tonsillectomy/adenoidectomy was performed in 7 subjects; 3 of these had obstructive sleep apnea, which resolved after the procedure in all three cases.

Intracranial hypertension occurred in three subjects. In two subjects the events resolved without interruption of Increlex™ treatment. Increlex™ treatment was discontinued in the third subject and resumed later at a lower dose without recurrence.

Mild elevations in the serum AST and LDH were found in a significant proportion of patients before and during treatment and no rise in levels of these serum enzymes led to treatment discontinuation. ALT elevations were occasionally noted during treatment. Renal and splenic lengths (measured by ultrasound) increased rapidly on Increlex™ treatment during the first years of therapy. This lengthening slowed down subsequently; though in some patients, renal and/or splenic length reached or surpassed the 95th percentile. Renal function (as defined by serum creatinine and calculated creatinine clearance) was normal in all patients, irrespective of renal growth. Elevations in cholesterol and triglycerides to above the upper limit of normal were observed before and during treatment. Echocardiographic evidence of cardiomegaly/valvulopathy was observed in a few individuals without associated clinical symptoms. Because of underlying disease and the lack of control group, the relation of the cardiac changes to drug treatment cannot be assessed.

Thickening of the soft tissues of the face was observed in several patients and should be monitored during Increlex™ treatment.

More resources:

Increlex

Increlex

Increlex - Includes detailed dosage instructions.

Increlex

Mecasermin

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