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Pixcolt 2.5 mg Tablets

For the prevention of VTE (VTEp) after elective hip or knee replacement surgery and the prevention of stroke and systemic embolism in patient with non-valvular atrial fibrillation (NVAF)

Ingredient: Apixaban
Multinational Partner: MINAPHARM
Launch Date: September 1, 2020
Pack: Box containing 3 blisters each of 10 film coated tablets

Product General

Disease Area
Thrombosis and Hemostasis
Insert leaflet
Publications
Guidelines

Attached Files

ASH_VTE Guideline_Snapshot_Full.pdf
ESC DIAB.pdf
2018ASH_Clinical_Practice_GuidelinesVTE_SnapshotAnticoagulation.pdf
2019-Afib-Guidelines-Made-Simple-Tool.pdf
ESC DIAB.pdf
NICE guidelines THR TKR.pdf
Q & A
Does the dose of Pixcolt need to be adjusted according to patient’s body weight?

No, Pixcolt dose is not affected by body weight which has been proved in ARISTOTLE trial which concluded that apixaban appears to be appropriate for patients with atrial fibrillation irrespective of body weight. Therefore, no dose adjustment required, unless criteria for dose reduction are met: AF Patients with at least 2 of the following: a) age≥80 years b) body weight≤60 kg c) serum creatinine≥1.5 mg/dl

Is there a reversal agent (antidote) for Pixcolt in case of bleeding?

All NOACs have a newly approved antidote Andexanet Alfa but it’s not available yet in EGYPT therefore in case of bleeding you may need fresh frozen plasma transfusion. But in fact, Pixcolt (apixaban) has the lowest bleeding tendency and considered the safest among all other NOACs. Administration of activated charcoal may be useful in the management of overdose or accidental ingestion.

How can I switch patient from warfarin to Pixcolt?

According to European Heart journal: Pixcolt can immediately be initiated once the INR is ≤2.0. If the INR is 2.0–2.5, NOACs can be started immediately or (better) the next day.

How can we switch a patient from a parental anticoagulant to Pixcolt?

From Low molecular weight heparin: NOACs can be initiated when the next dose of LMWH would be due. From Thrombexx: NOACs can be initiated when the next dose of thrombexx would be due

What should I tell patient when he/she misses a dose?

If the patient misses a dose of Pixcolt, tell him to take the medicine as soon as he remembers and then take the next tablet of pixcolt at the usual time, then continue as normal (to the previously scheduled dosing). The dose should not be doubled to make up for a missed dose

Does Pixcolt require monitoring of blood coagulation?

No, unlike warfarin, Apixaban does not need regular blood tests to monitor blood clotting levels, however, the patient should have a blood test to monitor your kidney and liver functions before starting Apixaban and then once a year thereafter.

Can Pixcolt be used in pregnant or lactating women?

For Nursing Mothers discontinue drug or discontinue nursing taking into account the importance of the drug to the mother. Pixcolt is Cateogry B in pregnancy but There are no adequate and well-controlled studies of Pixcolt in pregnant women

Can I use Pixcolt in patients with renal impairment?

In mild and moderate renal impairment CrCl>30ml/min: - In NVAF patients: No dose adjustment 2.5mg taken orally twice daily in patients with at least two of the following characteristics: age ≥80 years body weight≤60kg serum creatinine ≥1.5 mg/dL (133 µmol/l). - In DVT or PE patients: No dose adjustment required in DVT or PE patient In Severe renal impairment CrCl 15 – 29 ml/min - In NVAF patients: They should receive lower dose of Pixcolt 2.5mg twice daily - In DVT or PE patient: Pixcolt is to be used with caution

Can I use Pixcolt in patients with hepatic impairment?

No dose adjustment required in mild to moderate liver disease. Pixcolt is not recommended in severe hepatic disease (child pugh class C -most sever liver cirrhosis-) and contraindicated in hepatic diseases associated with coagulopathy or clinically relevant active bleeding risk.

What is the maximum dose for Pixcolt?

10 mg/day PO for most patients; 20 mg/day PO for initial treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE).

Can I use Pixcolt in dialysis patients?

Yes, Apixaban can be used in dialysis patient with dose of 2.5 mg. According to 2019 AHA guidelines Apixaban is the only NOAC to be used in hemodialysis patients.

How is pixcolt eliminated?

Elimination occurs via multiple pathways including metabolism, biliary excretion, and direct intestinal excretion, with approximately 27% of total apixaban clearance occurring via renal excretion Therefore, Pixcolt (apixaban) is considered the best choice for renal patient among other NOACs.

What about Pixcolt drug-drug interaction?

Inducers of CYP3A4 and P-gp: rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s Wort Inhibitors of CYP3A4 and P-gp Azole-antimycotics (ketoconazole, itraconazole, voriconazole and posaconazole) HIV protease inhibitors (ritonavir) Anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs and NSAIDs avoid concomitant use as bleeding risk increase

When Can the patient start Pixcolt after the surgery?

The patient can start Pixcolt once he becomes hemostable (from 12-14 hours post-surgery)

How can I use Pixcolt with Spinal / Epidural Anesthesia or Puncture?

A time interval of 20-30 hours (i.e., 2 x half-life) between the last dose of apixaban and catheter withdrawal should elapse, and at least one dose should be omitted before catheter withdrawal. The next dose of apixaban may be given at least 5 hours after catheter removal.

Can I use Pixcolt for patients who require Cardioversion?

Apixaban can be initiated or continued in NVAF patients who may require cardioversion.

Can I use Pixcolt for cancer Patient?

Efficacy and safety of apixaban in the treatment of DVT, treatment of PE, and prevention of recurrent DVT and PE in patients with active cancer have not been established.

What are the contraindications of Pixcolt?

- Active pathological bleeding - Severe hypersensitivity reaction to Apixaban e.g., anaphylactic reactions - Hepatic disease associated with coagulopathy and clinically relevant bleeding risk. - Lesion or condition if considered a significant risk factor for major bleeding : Current or recent gastrointestinal ulceration - Presence of malignant neoplasms at high risk of bleeding - Recent brain or spinal injury or ophthalmic surgery - Recent intracranial haemorrhage - Known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. - Concomitant treatment with any other anticoagulant agent e.g., unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc.)

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