Innohep Side Effects

Generic name: tinzaparin

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

Some side effects of Innohep 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 tinzaparin: subcutaneous solution

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

Stop using tinzaparin 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;

• chest pain; or

• pain or burning when you urinate.

Less serious side effects of tinzaparin may include:

• mild headache, dizziness;

• back pain;

• fever;

• pain, irritation, swelling, or bruising of the skin where the medicine was injected;

• nausea, vomiting, stomach pain, gas;

• diarrhea, constipation;

• mild skin rash; or

• sleep problems (insomnia).

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 tinzaparin: subcutaneous solution

Hematologic

Hematologic side effects including epistaxis (1.9%), hemorrhage (1.5%), hematoma (greater than 1%), thrombocytopenia (greater than 1%), anemia (greater than 1%), and hematuria (1%) have been reported. Other side effects including anorectal bleeding, cerebral/intracranial bleeding, gastrointestinal hemorrhage, hemarthrosis, hematemesis, hemoptysis, ocular hemorrhage, injection site bleeding, melena, purpura, retroperitoneal/intra-abdominal bleeding, vaginal hemorrhage, granulocytopenia, agranulocytosis, pancytopenia, and wound hematoma have been reported in ongoing or completed clinical trials or from post marketing experience.

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 generates 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.

Cardiovascular

Cardiovascular side effects including chest pain (2.3%), hypotension (greater than 1%), tachycardia (greater than 1%), hypertension (greater than 1%), and angina pectoris (greater than 1%) have been reported. Other side effects including myocardial infarction/coronary thrombosis, cardiac arrhythmias and thromboembolism have been reported in ongoing or completed clinical trials or from post marketing experience.

Dermatologic

Dermatologic side effects including rash (1.2%), bullous eruption (greater than 1%), erythematous rash (greater than 1%), and pruritus (greater than 1%) have been reported. Other side effects including epidermal necrolysis, ischemic necrosis, urticaria, and skin necrosis have been reported in ongoing or completed clinical trials or from post marketing experience. Diffuse alopecia in a diabetic man receiving tinzaparin (the active ingredient contained in Innohep) has also been reported.

A 66-year-old man with end-stage renal disease (who had been receiving dialysis for about a year) complained of hair loss from the right temporal area. He had been taking enoxaparin for 9 months to prevent extracorporeal blood clotting, but was switched to tinzaparin for the last three months. It was suspected that the alopecia was due to tinzaparin use. Tinzaparin was subsequently discontinued and enoxaparin was reinitiated. A gradual regrowth of hair was noted over the next few months, with a full restoration of normal hair growth at 18 months.

Respiratory

Respiratory tract symptoms including pulmonary embolism (2.3%) and dyspnea (1.2%) have been reported.

Hepatic

Hepatic side effects including cholestatic hepatitis and increases in hepatic enzymes have been reported in ongoing or completed clinical trials or from post marketing experience.

General

General side effects including headache (1.7%), pain (1.5%), fever (1.5%), insomnia (greater than 1%), and healing impairment (greater than 1%) have been reported. Other side effects including angioedema, dependent edema, and peripheral ischemia have been reported in ongoing or completed clinical trials or from post marketing experience.

Genitourinary

Genitourinary side effects including urinary tract infection (3.7%), dysuria (greater than 1.5%), and urinary retention (greater than 1%) have been reported. Other side effects including priapism have been reported in ongoing or completed clinical trials or from post marketing experience.

Gastrointestinal

Gastrointestinal side effects including nausea (1.7%), constipation (1.3%), flatulence (greater than 1%), dyspepsia (greater than 1%), vomiting (1%), abdominal pain (0.8%), and diarrhea (0.6%) have been reported in ongoing or completed clinical trials or from post marketing experience.

Musculoskeletal

Musculoskeletal side effects including back pain (1.5%) have been reported.

Local

Local side effects including injection site hematoma (greater than 1%) have been reported. Other side effects including cellulitis at the injection site, abscess, and necrosis have been reported in ongoing or completed clinical trials or from post marketing experience.

Nervous system

Nervous system side effects including dizziness (greater than 1%) have been reported

Psychiatric

Psychiatric side effects including confusion (greater than 1%) have been reported.

Immunologic

Immunologic side effects including infection (greater than 1%) have been reported.

Oncologic

Oncologic side effects including nonspecified neoplasm have been reported.

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