Clexane Forte Side Effects

Generic name: enoxaparin

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

Some side effects of Clexane Forte may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to enoxaparin: injectable injection, injectable subcutaneous, injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking enoxaparin (the active ingredient contained in Clexane Forte) hives; itching or burning skin; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using enoxaparin and call your doctor at once if you have a serious side effect such as:

• unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle injections, any bleeding that will not stop;

• easy bruising, purple or red pinpoint spots under your skin;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• black or bloody stools, coughing up blood or vomit that looks like coffee grounds;

• numbness, tingling, or muscle weakness (especially in your legs and feet);

• loss of movement in any part of your body;

• sudden weakness, severe headache, confusion, or problems with speech, vision, or balance; or

• trouble breathing.

Less serious side effects of enoxaparin may include:

• nausea, diarrhea;

• fever;

• swelling in your hands or feet; or

• mild pain, irritation, redness, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to enoxaparin: injectable solution

Hematologic

Hematologic side effects including wound hematoma (11%), anemia (3%), ecchymosis (3%), thrombocytopenia (1.5%), thrombocytosis, hemarthrosis, thrombosis, hypochromic anemia, and retroperitoneal hematoma have been reported. Clinical trials experience included reports of spinal/epidural hematoma and increased risk of hemorrhage.

Patients undergoing spinal/epidural anesthesia or puncture and anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids are at risk for long-term or permanent paralysis due to epidural or spinal hematoma. The risk of these events is increased by the use of indwelling epidural catheters or by concomitant use of platelet inhibitors, other anticoagulants, or drugs that affect hemostasis.

In one clinical study, compared with younger patients, the incidence of bleeding complications was higher in patients greater than or equal to 65-years-old.

Patients previously exposed to unfractionated heparin or a low-molecular-weight heparin appear to be more susceptible to developing heparin-induced thrombocytopenia (HIT) and HIT-related thromboembolic complications (e.g., transient ischemic attack, stroke) than those who were never exposed.

Heparin-induced thrombocytopenia (HIT) is an immune-mediated, prothrombotic reaction that occurs in 0.5% to 5% of patients treated with unfractionated heparin and in less than 1% of patients treated with a low molecular weight heparin (LMWH). The decrease in platelet count associated with HIT usually begins 5 to 14 days after starting heparin. However, patients with a previous exposure to heparin may have an abrupt decrease in platelets upon restarting heparin. Patients with LMWH-induced HIT exhibit a longer delay in the onset of symptoms compared with those who develop it from unfractionated heparin. Following discontinuation, platelet counts begin to recover within 4 days, but may take more than 2 weeks in patients with high-titer HIT antibodies. Thrombocytopenia is caused by heparin-dependent IgG antibodies that bind to a specific platelet protein, platelet factor 4 (PF4). The heparin-PF4-IgG immune complex binds to platelets causing platelet activation. The activated platelets cause release of platelet-derived procoagulant microparticles, which accelerate coagulation reactions and generate thrombin. LMWHs have a high cross-reactivity with circulating heparin-PF4-IgG immune complex. Factors associated with a higher risk for developing HIT-associated thrombosis include women, nonwhites, severity of thrombocytopenia, and lower body weight. Complications associated with HIT include exacerbation of venous thromboembolism, arterial or venous thrombosis, limb gangrene, stroke, and skin necrosis. The antibodies that cause HIT will usually disappear after approximately 3 months; therefore, use of unfractionated heparin or LMWH may be considered in a patient with a history of HIT if the antibody test is negative.

Factors associated with an increased risk of bleeding include high doses, advanced age, renal dysfunction, and concomitant use of other drugs that affect hemostasis.

Hepatic

Hepatic side effects have included transient elevations in liver function tests.

Local

Local side effects have included pain, erythema, ecchymosis, and hematoma. Rarely, painful, red induration and necrotic ulcerations at the injection site have been reported. Skin necrosis distant from the injection site has also been reported.

Skin necrosis occasionally accompanies heparin-associated thrombocytopenia and thrombosis syndrome. This complication is thought to occur less with enoxaparin than with unfractionated heparin. However, a recent report noted the occurrence of skin necrosis and associated thrombocytopenia with low molecular weight heparin use. If late-onset skin necrosis, thrombocytopenia, and/or thromboembolism occur during use, immediate discontinuation of low-molecular weight heparin is mandatory in order to avoid potentially fatal thromboembolic complications.

Hypersensitivity

Hypersensitivity side effects including systemic allergic reactions, pruritus, urticaria, and anaphylactoid reactions have been reported in postmarketing experience. A case of angioedema has been reported.

Dermatologic

Dermatologic side effects have included vesiculobullous rash, purpura, and cutaneous vasculitis. At least two cases of bullous pemphigoid-like eruption and one rare case of enoxaparin-induced ischemic skin necrosis have been reported.

Respiratory

Respiratory side effects have included lung edema, pneumonia, and dyspnea.

Cardiovascular

Cardiovascular side effects have included atrial fibrillation, heart failure, edema, and peripheral edema.

Gastrointestinal

Gastrointestinal side effects have included nausea and diarrhea.

Metabolic

One case of hyperlipidemia with marked hypertriglyceridemia was reported in a diabetic pregnant woman, although causality has not been determined.

Metabolic side effects have rarely included hyperlipidemia. Postmarketing reports have included cases of hyperkalemia. Most of these reports occurred in patients who also had conditions that tend toward the development of hyperkalemia (e.g., renal dysfunction, concomitant potassium-sparing drugs, administration of potassium, and hematoma in body tissues).

Genitourinary

Genitourinary side effects have included hematuria.

Nervous system

Nervous system side effects have included confusion.

Other

Other side effects have included fever.

General

Any unexplained decrease in blood pressure and/or hematocrit as well as unexplained symptoms should prompt consideration of a possible hemorrhagic event.

In general, hemorrhagic side effects have occurred in 3% to 7% of patients. A meta-analysis of published studies reported an overall incidence of major bleeding with low molecular weight heparins of 0.7% to 1.4%. Hemorrhage may occur at any site in the body.

Musculoskeletal

In a study involving pregnant women (n=120) requiring thromboprophylaxis, clinically significant bone loss (i.e., 10% or greater) in the femur occurred in approximately 2% to 2.5% of patients regardless if they received enoxaparin (the active ingredient contained in Clexane Forte) (68.4 mg/day) or unfractionated heparin (17,380 units/day) for approximately 26 to 27 weeks.

Musculoskeletal side effects have included osteoporosis.

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