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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Increlex:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Increlex Side Effects - for the Professional

Increlex

Most Serious and/or Most Frequently Observed Adverse Reactions:

• Hypoglycemia [see Warnings and Precautions (5.1), Adverse Reaction (6.2)]
• Hypersensitivity and Allergic Reactions, including Anaphylaxis [see Contraindications (4.2), Warnings and Precautions (5.2), Adverse Reaction (6.2)]
• Intracranial hypertension (IH) [see Warnings and Precautions (5.3), Adverse Reaction (6.2]
• Tonsillar and Adenoidal Hypertrophy and related complications [see Warnings and Precautions (5.4) , Adverse Reactions (6.2)]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

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 reactions. Adverse reactions 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. Rise in levels of these serum enzymes did not lead 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. The relation of these cardiac changes to drug treatment cannot be assessed due to underlying disease and the lack of a control group.

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

As with all therapeutic proteins, there is potential for immunogenicity. 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., attenuation of growth). The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Increlex® with the incidence of antibodies to other products may be misleading.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of Increlex®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Systemic hypersensitivity; anaphylaxis, generalized urticaria, angioedema, dyspnea

In the post-marketing setting, the frequency of cases indicative of anaphylaxis was estimated to be 0.3%. Symptoms included hives, angioedema, and dyspnea, and some patients required hospitalization. Upon re-administration, symptoms did not re-occur in all patients.

Local allergic reactions at the injection site; pruritis, urticaria.

Top

Side Effects by Body System - for Healthcare Professionals

Local

Local side effects have included lipohypertrophy and bruising.

Cardiovascular

Cardiovascular side effects have included cardiac murmur.

Gastrointestinal

Gastrointestinal side effects have included vomiting.

Hematologic

Hematologic side effects have included thymus hypertrophy.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and pain in extremities. Slipped capital femoral epiphysis and progression of scoliosis has been reported.

Respiratory

Respiratory side effects have included snoring and tonsillar hypertrophy.

Metabolic

Metabolic side effects have included hypoglycemia.

Other

Other side effects have included otitis media, serous otitis media, hypoacusis, fluid in middle ear, ear pain and abnormal tympanometry.

Nervous system

Nervous system side effects have included headache, dizziness, and convulsions. Intracranial hypertension has been reported.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis, generalized urticaria, angioedema, and dyspnea.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.