APIXA 5MG TABS 14s

Apixa-Q contains apixaban, a highly selective, reversible, direct inhibitor of coagulation Factor Xa. Factor Xa is a critical enzyme at the convergence of the extrinsic and intrinsic coagulation pathways, and its inhibition prevents thrombin generation and fibrin clot formation without requiring antithrombin as a cofactor.

Unlike warfarin, apixaban does not require routine INR monitoring, has fewer drug and food interactions, and has a rapid onset of action (peak effect in 3–4 hours). In Kenya, apixaban represents a significant advance in anticoagulation therapy for patients at risk of stroke, deep vein thrombosis (DVT), or pulmonary embolism (PE), particularly those for whom warfarin monitoring is logistically challenging.

Approved Indications

•       Prevention of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF)

•       Treatment of deep vein thrombosis (DVT)

•       Treatment of pulmonary embolism (PE)

•       Prevention of recurrent DVT and PE following acute treatment

•       Prevention of VTE in adults after elective hip or knee replacement surgery

General Instructions

Take apixaban with or without food. Swallow tablets whole. For twice-daily dosing, space doses approximately 12 hours apart. Do not crush or chew unless directed, crushed tablets may be mixed with water or apple juice immediately before administration if swallowing is difficult.

Dosage, Adults

Atrial fibrillation stroke prevention: 5 mg twice daily (reduced to 2.5 mg twice daily if 2 of 3 criteria met: age ≥ 80, weight ≤ 60 kg, serum creatinine ≥ 133 micromol/L). DVT/PE treatment: 10 mg twice daily for 7 days, then 5 mg twice daily. VTE prophylaxis post-orthopaedic surgery: 2.5 mg twice daily.

Elderly Patients

No dose adjustment required based on age alone; apply dose-reduction criteria for AF (see above).

Missed Dose

For twice-daily dosing: take the missed dose on the same day as soon as remembered; take the next dose at the usual time. Do not take two doses in one day.

Duration of Treatment

AF: indefinite (unless risk-benefit changes). DVT/PE: minimum 3 months; reassess thereafter. Post-surgery: 10–35 days depending on procedure.

Common Side Effects

•       Bruising and minor bleeding (skin, gums, nosebleeds)

•       Anaemia (due to occult bleeding)

•       Nausea

Less Common Side Effects

•       Haematuria (blood in urine)

•       Gastrointestinal bleeding (melaena, rectal bleeding)

•       Hypotension

•       Skin rash

Serious / Seek Immediate Medical Attention

•       Major haemorrhage, intracranial, gastrointestinal, or retroperitoneal bleeding. Seek emergency care immediately for severe or uncontrolled bleeding

•       Spinal or epidural haematoma, risk increased with neuraxial anaesthesia or spinal puncture; can cause permanent paralysis

•       Thrombocytopenia (rare)

•       Premature discontinuation significantly increases stroke risk in AF patients, never stop without medical advice and without initiating alternative anticoagulation if needed.

•       There is no specific routine antidote available in Kenya for apixaban; andexanet alfa (the specific reversal agent) is not widely accessible. In bleeding emergencies, activated charcoal (if within 2 hours), supportive care, and haematology consultation are required.

•       In patients undergoing neuraxial anaesthesia (spinal/epidural), follow specific timing guidelines for apixaban interruption to avoid spinal haematoma.

•       Monitor for signs of bleeding: unusual bruising, prolonged bleeding from cuts, pink/brown urine, red/black tarry stools, coughing blood.

•       Renal function affects apixaban clearance (25% renally eliminated), monitor eGFR periodically.

•       Apixaban is not recommended in patients with CrCl < 15 mL/min or those on dialysis for stroke prevention.

Always inform your pharmacist and prescriber about all medicines, supplements, and herbal remedies you are currently taking.

Strong dual CYP3A4/P-gp inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): Significantly increase apixaban exposure, reduce dose to 2.5 mg twice daily if standard 5 mg dose and 2 other dose-reduction criteria met

Strong dual CYP3A4/P-gp inducers (e.g., rifampicin, carbamazepine, phenytoin, St John's Wort): Significantly decrease apixaban levels, increased thromboembolism risk; avoid combination

Aspirin / NSAIDs: Increased bleeding risk, use with caution; avoid if possible

Other anticoagulants (heparin, warfarin, dabigatran): Additive bleeding risk, avoid concurrent use except for specific bridging protocols

SSRIs / SNRIs: Increased risk of bleeding, monitor carefully

Rifampicin (common in Kenya for TB therapy): Reduces apixaban AUC by ~54%, DOAC efficacy significantly compromised; consider warfarin for patients on anti-TB therapy

Store below 30°C in a dry place. Keep in the original blister pack. Keep out of reach of children. Do not use beyond the expiry date.

Apixaban is a Prescription Only Medicine (POM) in Kenya and is listed under regulated anticoagulants. Given the bleeding risk associated with anticoagulant therapy, prescribing requires specialist or medical officer assessment. Pharmily requires a valid prescription and recommends patients present their most recent renal function results at dispensing.

Apixaban is increasingly replacing warfarin across Kenyan hospitals and community pharmacies due to its predictable pharmacokinetics and freedom from INR monitoring. However, patient counselling must emphasise the critical importance of adherence, unlike warfarin, where subtherapeutic INR is detectable, under-dosing with apixaban is clinically silent until a thromboembolic event occurs.

A critical Kenyan-context interaction: patients on anti-TB therapy (rifampicin-containing regimens) experience a ~54% reduction in apixaban exposure. In such patients, warfarin with INR monitoring is strongly preferred. Document and flag this interaction prominently at dispensing.

When dispensing to patients with renal impairment, calculate CrCl using the Cockcroft-Gault equation, the 2.5 mg dose-reduction criteria for AF (age ≥ 80, weight ≤ 60 kg, creatinine ≥ 133 micromol/L, any 2 of 3) must be applied correctly. Pharmily's clinical review process should capture these parameters.

Do I need regular blood tests with Apixa-Q?

A: Unlike warfarin, you do not need routine INR blood tests. However, your doctor may periodically check your kidney function and blood count to ensure the medicine is safe for you.

What should I do if I cut myself or start bleeding while on Apixa-Q?

A: For minor cuts, apply firm pressure for longer than usual and elevate the area. For serious or uncontrolled bleeding, go to the emergency room immediately and inform the medical team that you are taking apixaban.

Can I take painkillers with Apixa-Q?

A: Paracetamol is generally safe. Avoid ibuprofen, diclofenac, aspirin, and other NSAIDs unless specifically prescribed by a doctor; they significantly increase your bleeding risk when combined with apixaban.

Is apixaban safe if I am also being treated for tuberculosis (TB)?

A: This is an important interaction in Kenya. The TB drug rifampicin significantly reduces apixaban levels in the blood, making it much less effective. If you are on TB treatment, your doctor should consider switching to warfarin with INR monitoring instead.