Innohep
- Generic Name: tinzaparin
- Brand Name: Innohep
- Drug Class: Low Molecular Weight Heparin
Innohep (Tinzaparin) side effects drug center
Innohep Side Effects Center
Innohep (tinzaparin) is a blood thinner (anticoagulant) used together with warfarin (Coumadin) to treat a type of blood clot called deep vein thrombosis, or DVT. This condition sometimes occurs with a blood clot in lungs (pulmonary embolism, or PE). Common side effects of Innohep include:
- injection site reactions (pain, bruising, redness, irritation, and swelling),
- headache,
- dizziness,
- back pain,
- nosebleed,
- fever,
- nausea,
- vomiting,
- stomach pain,
- gas,
- diarrhea,
- constipation,
- skin rash, or
- sleep problems (insomnia).
Tell your doctor if you have serious side effects of Innohep including:
- easy bleeding or bruising,
- dark urine,
- persistent nausea/vomiting/loss of appetite, or
- yellowing eyes or skin.
The recommended dose of Innohep for the treatment of DVT with or without PE is 175 anti-Xa IU/kg of body weight, administered subcutaneously once daily for at least 6 days and until the patient is adequately anticoagulated with warfarin (INR at least 2.0 for two consecutive days). Innohep may interact with dextran, aspirin and other salicylates, and other medication used to prevent blood clots. Tell your doctor all medication you are taking. During pregnancy, Innohep should be used only when prescribed. If you become pregnant or think you may be pregnant, tell your doctor immediately. Since the benzyl alcohol in Innohep can affect a fetus a preservative-free product should be used in pregnant women if possible. It is not known whether this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Innohep (tinzaparin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, dark urine, persistent nausea/vomiting/loss of appetite, yellowing eyes/skin.
This medication may rarely cause serious bleeding. (See also Warning section.) Tell your doctor right away if you have any signs of serious bleeding, including: shortness of breath, coughing up blood, chest pain, cold/blue fingers or toes, unusual dizziness, fast/irregular heartbeat, joint/muscle pain, mental/mood changes (such as confusion), difficulty moving, numbness/tingling, severe stomach/abdominal pain, bloody/black/tarry stools, red/pinkish urine, vomit that looks like coffee grounds.
Get medical help right away if you have any very serious side effects, including: seizures, fainting, severe/persistent headache, slurred speech, vision problems, weakness on one side of the body.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Innohep (Tinzaparin)
Innohep Professional Information
SIDE EFFECTS
Bleeding: Bleeding is the most common adverse event associated with INNOHEP® (tinzaparin sodium injection); however, the incidence of major bleeding is low. In clinical trials, the definition of major bleeding included bleeding accompanied by ≥ 2 gram/dL decrease in hemoglobin, requiring transfusion of 2 or more units of blood products, or bleeding which was intracranial, retroperitoneal, or into a major prosthetic joint. The data are provided in Table 4.
Table 4 : Major Bleeding Events1 in Treatment of Acute Deep
Vein Thrombosis With or Without Pulmonary Embolism
| Indication | Treatment Group1 | |
| Treatment of Acute DVT With or Without PE | INNOHEP® (tinzaparin) N=519 % |
Heparin N=524 % |
| Major Bleeding Events2 | 0.83 | 2.73 |
| 1 INNOHEP® (tinzaparin) 175 IU/kg once
daily SC. Unfractionated heparin initial IV bolus of 5,000 IU followed
by continuous IV infusion adjusted to an aPTT of 1.5 to 2.5 or initial
IV bolus of 50 IU/kg followed by continuous IV infusion adjusted to an
aPTT of 2.0 to 3.0. In all groups treatment continued for approximately
6 to 8 days, and all patients received oral anticoagulant treatment commencing
in the first 2 to 3 days. 2 Bleeding accompanied by ≥ 2 gram/dL decline in hemoglobin, requiring transfusion of or more units of blood products, or bleeding which was intracranial, retroperitoneal, or into a major prosthetic joint. 3 The 95% CI on the difference in major bleeding event rates (1.9%) was 0.33%, 3.47%. |
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Fatal or nonfatal hemorrhage from any tissue or organ can occur. The signs, symptoms, and severity will vary according to the location and degree or extent of the bleeding. Hemorrhagic complications may present as, but are not limited to, paralysis; paresthesia; headache, chest, abdomen, joint, muscle or other pain; dizziness; shortness of breath, difficult breathing or swallowing; swelling; weakness; hypotension, shock, or coma. Therefore, the possibility of hemorrhage should be considered in evaluating the condition of any anticoagulated patient with complaints which do not indicate an obvious diagnosis (see WARNINGS, Hemorrhage).
Thrombocytopenia
In clinical studies thrombocytopenia was identified in 1% of patients treated with INNOHEP® (tinzaparin) . Severe thrombocytopenia (platelet count < 50,000/mm³) occurred in 0.13% (see WARNINGS, Thrombocytopenia).
Elevations of Serum Aminotransferases
Asymptomatic increases in aspartate (AST [SGOT]) and/or alanine (ALT [SGPT]) aminotransferase levels greater than 3 times the upper limit of normal of the laboratory reference range have been reported in up to 8.8% and 13% for AST and ALT, respectively, of patients receiving tinzaparin sodium for the treatment of DVT. Similar increases in aminotransferase levels have also been observed in patients and healthy volunteers treated with heparin and other low molecular weight heparins. Such elevations are reversible and are rarely associated with increases in bilirubin (see PRECAUTIONS, Laboratory Tests).
Local Reactions
Mild local irritation, pain, hematoma, and ecchymosis may follow SC injection of INNOHEP® (tinzaparin) . Injection site hematoma has been reported in approximately 16% of patients treated with INNOHEP® (tinzaparin) .
Hypersensitivity
Anaphylactic/anaphylactoid reactions may occur in association with INNOHEP® use (see CONTRAINDICATIONS and WARNINGS).
Adverse Events
Adverse events with INNOHEP® (tinzaparin) or heparin reported at a frequency of ≥ 1% in clinical trials with patients undergoing treatment for proximal DVT with or without PE, are provided in Table 5.
Table 5 : Adverse Events Occurring in ≥ 1% in Treatment
of Acute Deep Vein Thrombosis With or Without Pulmonary Embolism Studies
| Adverse Events | Treatment Group1 | |
| INNOHEP® (tinzaparin) N=519 n (%) |
Heparin N=524 n (%) |
|
| Urinary Tract Infection | 19 (3.7%) | 18 (3.4%) |
| Pulmonary Embolism | 12 (2.3%) | 12 (2.3%) |
| Chest Pain | 12 (2.3%) | 8 (1.5%) |
| Epistaxis | 10 (1.9%) | 7 (1.3%) |
| Headache | 9 (1.7%) | 9 (1.7%) |
| Nausea | 9 (1.7%) | 10 (1.9%) |
| Hemorrhage NOS | 8 (1.5%) | 23 (4.4%) |
| Back Pain | 8 (1.5%) | 2 (0.4%) |
| Fever | 8 (1.5%) | 11 (2.1%) |
| Pain | 8 (1.5%) | 7 (1.3%) |
| Constipation | 7 (1.3%) | 9 (1.7%) |
| Rash | 6 (1.2%) | 8 (1.5%) |
| Dyspnea | 6 (1.2%) | 9 (1.7%) |
| Vomiting | 5 (1.0%) | 8 (1.5%) |
| Hematuria | 5 (1.0%) | 6 (1.1%) |
| Abdominal Pain | 4 (0.8%) | 6 (1.1%) |
| Diarrhea | 3 (0.6%) | 7 (1.3%) |
| Anemia | 0 | 7 (1.3%) |
| NOS = not otherwise specified 1 INNOHEP® (tinzaparin) 175 IU/kg once daily SC. Unfractionated heparin initial IV bolus of 5,000 IU followed by continuous IV infusion adjusted to an aPTT of 1.5 to 2.5 or initial IV bolus of 50 IU/kg followed by continuous IV infusion adjusted to an aPTT of 2.0 to 3.0. In all groups treatment continued for approximately 6 to 8 days, and all patients received oral anticoagulant treatment commencing in the first 2 to 3 days. |
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Other Adverse Events in Completed or Ongoing Trials
Other adverse events reported at a frequency of ≥ 1% in 4,000 patients who received INNOHEP® (tinzaparin) in completed or ongoing clinical trials are listed by body system:
Body as a Whole: injection site hematoma, reaction unclassified.
Cardiovascular Disorders, General: hypotension, hypertension.
Central and Peripheral Nervous System Disorders: dizziness.
Gastrointestinal System Disorders: flatulence, gastrointestinal disorder (not otherwise specified), dyspepsia.
Heart Rate and Rhythm Disorders: tachycardia.
Myo-, Endo-, Pericardial and Valve Disorders: angina pectoris.
Platelet, Bleeding and Clotting Disorders: hematoma, thrombocytopenia.
Psychiatric Disorders: insomnia, confusion.
Red Blood Cell Disorders: anemia.
Resistance Mechanism Disorders: healing impaired, infection.
Respiratory System Disorders: pneumonia, respiratory disorder.
Skin and Appendages Disorders: rash erythematous, pruritus, bullous eruption, skin disorder.
Urinary System Disorders: urinary retention, dysuria.
Vascular (Extracardiac) Disorders: thrombophlebitis deep, thrombophlebitis leg deep.
Serious adverse events reported in clinical trials or from post-marketing experience are included in Tables 6 and 7, respectively:
Table 6 : Serious Adverse Events Associated With INNOHEP® (tinzaparin)
in Clinical Trials
| Category | Serious Adverse Event |
| Bleeding-related | Anorectal bleeding |
| Cerebral/intracranial bleeding | |
| Epistaxis | |
| Gastrointestinal hemorrhage | |
| Hemarthrosis | |
| Hematemesis | |
| Hematuria | |
| Hemopericardium | |
| Hemorrhage NOS | |
| Injection site bleeding | |
| Melena | |
| Purpura | |
| Retroperitoneal/intra-abdominal bleeding | |
| Vaginal hemorrhage | |
| Wound hematoma | |
| Organ dysfunction | Angina pectoris |
| Cardiac arrhythmia | |
| Dependent edema | |
| Myocardial infarction/coronary thrombosis | |
| Thromboembolism | |
| Fetal/neonatal | Congenital anomaly |
| Fetal death | |
| Fetal distress | |
| Cutaneous | Bullous eruption |
| Erythematous rash | |
| Maculopapular rash | |
| Skin necrosis | |
| Hematologic | Granulocytopenia |
| Thrombocytopenia | |
| Allergic reactions | Allergic reaction |
| Injection site reaction | Cellulitis |
| Neoplastic | Neoplasm |
Table 7 : Other Serious Adverse Events Associated With INNOHEP® (tinzaparin)
from Post-Marketing Surveillance
| Category | Serious Adverse Event |
| Organ dysfunction | Cholestatic hepatitis |
| Increase in hepatic enzymes | |
| Peripheral ischemia | |
| Priapism | |
| Bleeding-related | Hematoma |
| Hemoptysis | |
| Ocular hemorrhage | |
| Rectal bleeding | |
| Cutaneous reactions | Epidermal necrolysis |
| Ischemic necrosis | |
| Stevens-Johnson syndrome | |
| Urticaria | |
| Hematologic | Agranulocytosis |
| Pancytopenia | |
| Thrombocythemia | |
| Injection site reactions | Abscess |
| Necrosis | |
| Allergic reactions | Allergic purpura |
| Angioedema | |
| Fetal/neonatal | Cutis aplasia of the scalp |
| Neonatal hypotonia | |
| General | Acute febrile reaction |
Ongoing Safety Surveillance
When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis (see BOXED WARNING).
Spinal epidural hematoma in association with neuraxial anesthesia or spinal puncture with INNOHEP (tinzaparin) has been reported.
Spinal epidural hematoma with INNOHEP® (tinzaparin) administered at a therapeutic dose has been reported in at least one patient who had not received neuraxial anesthesia or spinal puncture.
Read the entire FDA prescribing information for Innohep (Tinzaparin)
&Copy; Innohep Patient Information is supplied by Cerner Multum, Inc. and Innohep Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.