Plasiver Side effects

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What are the possible side effects of Plasiver?

Get emergency medical help if you have any signs of an allergic reaction to Plasiver: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Plasiver and call your doctor at once if you have any of these serious side effects:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Plasiver in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Clinical Studies Experience: Plasiver has been evaluated for safety in >44,000 patients, including >12,000 patients treated for ≥1 year. The clinically relevant adverse effects observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed as follows. Plasiver 75 mg/day was well tolerated compared to ASA 325 mg/day in CAPRIE. The overall tolerability of Plasiver in this study was similar to ASA, regardless of age, gender and ethnicity.

Haemorrhagic Disorders: In CAPRIE, in patients treated with either Plasiver or ASA, the overall incidence of any bleeding was 9.3%. The incidence of severe cases was 1.4% for Plasiver and 1.6% for ASA. In patients that received Plasiver, gastrointestinal bleeding occurred at a rate of 2% and required hospitalisation in 0.7%. In patients that received ASA, the corresponding rates were 2.7% and 1.1%, respectively.

The overall incidence of other bleedings was higher in patients that received Plasiver compared to ASA (7.3% vs 6.5%). However, the incidence of severe events was similar in both treatment groups (0.6% vs 0.4%). The most frequently reported events in both treatment groups were: Purpura/bruising and epistaxis. Other less frequently reported events were haematoma, haematuria and eye bleeding (mainly conjunctival).

The incidence of intracranial bleeding was 0.4% in patients that received Plasiver and 0.5% for patients that received ASA.

In CURE, the administration of Plasiver + ASA as compared to placebo + ASA was not associated with a statistically significant increase in life-threatening bleeds (event rates 2.2% vs 1.8%) or fatal bleeds (0.2% vs 0.2%), but the risk of major, minor and other bleedings was significantly higher with Plasiver + ASA: Major bleeds (3.7% Plasiver + ASA vs 2.7% placebo + ASA), non-life-threatening major bleeds (1.6% Plasiver + ASA vs 1% placebo + ASA), primarily gastrointestinal and at puncture sites, and minor bleeds (5.1% Plasiver + ASA vs 2.4% placebo + ASA). The incidence of intracranial bleeding was 0.1% in both groups.

The major bleeding event rate for Plasiver + ASA was dose-dependent on ASA (<100 mg: 2.6%; 100-200 mg: 3.5%; >200mg: 4.9%) as was the major bleeding event rate for placebo + ASA (<100 mg: 2%; 100-200 mg: 2.3%; >200 mg: 4%).

The risk of bleeding (life-threatening, major, minor, other) decreased during the course of the trial: 0-1 months [Plasiver: 599/6259 (9.6%); placebo: 413/6303 (6.6%)], 1-3 months [Plasiver: 276/6123 (4.5%); placebo: 144/6168 (2.3%)], 3-6 months [Plasiver: 228/6037 (3.8%); placebo: 99/6048 (1.6%)], 6-9 months [Plasiver: 162/5005 (3.2%); placebo: 74/4972 (1.5%)], 9-12 months [Plasiver: 73/3841 (1.9%); placebo: 40/3844 (1%)].

There was no excess in major bleeds within 7 days after coronary bypass graft surgery in patients who stopped therapy >5 days prior to surgery (4.4% Plasiver + ASA vs 5.3% placebo + ASA). In patients who remained on therapy within 5 days of bypass graft surgery, the event rate was 9.6% for Plasiver + ASA and 6.3% for placebo + ASA.

In CLARITY, there was an overall increase in bleeding in the Plasiver + ASA group (17.4%) versus the placebo + ASA group (12.9%). The incidence of major bleeding was similar between groups (1.3% vs 1.1% for the Plasiver + ASA and the placebo + ASA groups, respectively). This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy. The incidence of fatal bleeding (0.8% vs 0.6% in the Plasiver + ASA and the placebo + ASA groups, respectively) and intracranial hemorrhage (0.5% vs 0.7% in the Plasiver + ASA and the placebo + ASA groups, respectively) was low and similar in both groups.

In COMMIT, the overall rate of noncerebral major bleeding or cerebral bleedings was low and similar in both groups (0.6% vs 0.5% in the Plasiver + ASA and the placebo + ASA groups, respectively).

In ACTIVE-A, the rate of major bleeding was greater in the Plasiver + ASA group than in the placebo + ASA group (6.7% vs 4.3%). Major bleeding was mostly of extracranial origin in both groups (5.3% in the Plasiver + ASA group; 3.5% in the placebo + ASA group), mainly in the gastrointestinal tract (3.5% vs 1.8%). There was an excess of intracranial bleeding in the Plasiver + ASA treatment group compared to the placebo + ASA group (1.4% vs 0.8%, respectively). There was no statistically significant difference in the rates of fatal bleeding and hemorrhagic stroke (0.8% and 0.6%, respectively) between groups.

Haematological Disorders: In CAPRIE, severe neutropenia (<0.45 x 109/L) was observed in 4 patients (0.04%) that received Plasiver and 2 patients (0.02%) that received ASA. Two of the 9599 patients who received Plasiver and none of the 9586 patients who received ASA had neutrophil counts of zero.

One case of aplastic anaemia occurred on Plasiver treatment.

The incidence of severe thrombocytopenia (<80 x 109/L) was 0.2% on Plasiver and 0.1% on ASA; very rare cases of platelet count ≤30 g/L have been reported.

In CURE and CLARITY, the number of patients with thrombocytopenia or neutropenia was similar in both groups.

Other clinically relevant adverse drug reactions pooled from CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies with an incidence >0.1% as well as all serious and relevant adverse drug reactions are listed as follows.

The following CIOMS frequency rating is used: Very common (≥10%); common (≥1 and <10%); uncommon (≥0.1 and <1%); rare (≥0.01 and <0.1%); very rare (<0.01%); unknown (cannot be estimated from available data).

Central and Peripheral Nervous System Disorders: Uncommon: Headache, dizziness and paraesthesia. Rare: Vertigo.

Gastrointestinal System Disorders: Common: Dyspepsia, abdominal pain, diarrhoea. Uncommon: Nausea, gastritis, flatulence, constipation, vomiting, gastric and duodenal ulcer.

Platelet, Bleeding and Clotting Disorders: Uncommon: Increased bleeding time and decreased platelets.

Skin and Appendages Disorders: Uncommon: Rash and pruritus.

White Cell and RES Disorders: Uncommon: Leucopenia, decreased neutrophils and eosinophilia.

Post-Marketing Experience: Bleeding is the most common reaction reported in the post-marketing experience and was mostly reported during the 1st month of treatment.

Bleeding: Some cases were reported with fatal outcome (especially intracranial, gastrointestinal and retroperitoneal haemorrhage); serious cases of skin bleeding (purpura), musculoskeletal bleeding (haemarthrosis, haematoma), eye bleeding (conjunctival, ocular, retinal), epistaxis, respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), haematuria and haemorrhage of operative wound have been reported; cases of serious haemorrhage have been reported in patients taking Plasiver concomitantly with ASA or Plasiver with ASA and heparin.

Frequencies for the following adverse reactions are not known (cannot be estimated form available data).

Blood and Lymphatic System Disorders: Serious cases of bleeding, mainly skin, musculoskeletal, eye (conjunctival, ocular, retinal) and respiratory tract bleeding, epistaxis, haematuria and haemorrhage of operative wound; cases of bleeding with fatal outcome (especially intracranial, gastrointestinal and retroperitoneal haemorrhage); agranulocytosis, aplastic anaemia/pancytopenia, TTP, acquired haemophilia A.

Immune System Disorders: Anaphylactoid reactions, serum sickness; cross-reactive drug hypersensitivity among thienopyridines (eg, ticlopidine, prasugrel).

Psychiatric Disorders: Confusion, hallucinations.

Nervous System Disorder: Taste disturbances.

Vascular Disorders: Vasculitis, hypotension.

Respiratory, Thoracic and Mediastinal Disorders: Bronchospasm, interstitial pneumonitis, eosinophilic pneumonia.

Gastrointestinal Disorders: Colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis.

Hepatobiliary Disorders: Hepatitis, acute liver failure.

Skin and Subcutaneous Tissue Disorders: Maculopapular, erythematous or exfoliative rash, urticaria, pruritus, angioedema, bullous dermatitis (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic (DRESS), eczema, lichen planus.

Musculoskeletal, Connective Tissue and Bone Disorders: Arthralgia, arthritis, myalgia.

Renal and Urinary Disorders: Glomerulopathy.

General Disorders and Administration Site Conditions: Fever.

Investigations: Abnormal liver function test, increased blood creatinine.

What is the most important information I should know about Plasiver?

Plasiver contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Plasiver should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation.

Plasiver is contraindicated in patients with pheochro-mocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. Such hypertensive crises may be controlled by phen-tolamine.

Plasiver is contraindicated in patients with known sensitivity or intolerance to the drug.

Plasiver should not be used in epileptics or patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.

References

  1. DTP/NCI. "clopidogrel: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  2. European Chemicals Agency - ECHA. "Thieno[3,2-c]pyridine-5(4H)-acetic acid, α-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (αS)-: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
  3. HSDB. "CLOPIDOGREL". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Plasiver are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Plasiver. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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