CARFILNAT (CARFILZOMIB) 60MG VIAL

Carfilnat contains carfilzomib (Kyprolis®), a targeted cancer medicine belonging to a class called proteasome inhibitors. It is used for the treatment of multiple myeloma — a cancer of plasma cells (a type of white blood cell found in the bone marrow). Multiple myeloma cells produce excessive amounts of abnormal proteins and are heavily dependent on proteasomes (the cell's protein recycling machinery) to survive. Carfilzomib blocks these proteasomes, causing a toxic build-up of proteins inside the cancer cells that ultimately kills them.

Carfilzomib binds irreversibly to its target — meaning each dose provides at least 48 hours of proteasome inhibition. It is used in patients whose multiple myeloma has returned (relapsed) or stopped responding to other treatments (refractory). It is always administered in a specialist oncology or haematology centre.

Approved Indications

•     Relapsed or refractory multiple myeloma in adults who have received 1 or more prior lines of therapy, as monotherapy

•     In combination with dexamethasone (Kd)

•     In combination with lenalidomide + dexamethasone (KRd)

•     In combination with daratumumab + dexamethasone (DKd)

•     In combination with isatuximab + dexamethasone (IsaKd)

All dosing decisions are made exclusively by the treating oncologist/haematologist based on body surface area (mg/m²) and clinical response.

Typical Schedule — Twice-Weekly (e.g., KRd regimen)

•     Cycle 1, Days 1 & 2: 20 mg/m² IV

•     From Day 8 onward: escalate to 36 mg/m² if tolerated

•     Administered on Days 1, 2, 8, 9, 15, 16 of each 28-day cycle

Typical Schedule — Once-Weekly (e.g. Kd regimen)

•     Cycle 1, Day 1: 20 mg/m² IV; escalate to 70 mg/m² from Day 8 if tolerated

Reconstitution

•     Add 29 mL sterile water for injection slowly down the inside of the vial wall. Gently swirl for 1 minute. DO NOT SHAKE — shaking causes foaming.

•     Resulting concentration: 2 mg/mL

Premedication and Hydration

•     Dexamethasone: Must be given 30 minutes to 4 hours before each carfilzomib infusion during Cycle 1, and whenever infusion reactions occur

•     Hydration: Adequate IV and oral hydration before and after each dose is essential to protect kidney function

Common (may affect more than 1 in 10 patients)

•     Fatigue and weakness

•     Nausea and diarrhoea

•     Peripheral oedema (swelling of ankles and feet)

•     Anaemia, neutropenia, thrombocytopenia (low blood counts)

•     Upper respiratory infections

•     Dyspnoea (shortness of breath)

•     Hypertension — can be significant

Serious — Tell Your Oncology Team Immediately

•     Pulmonary toxicity: Acute respiratory distress syndrome (ARDS), respiratory failure, pneumonitis

•     Infusion reactions: Fever, chills, joint/muscle pain, facial swelling, breathlessness — may occur during or up to 24 hours after infusion

•     Acute renal failure — ensure adequate hydration

•     Tumour lysis syndrome (TLS): especially in patients with high tumour burden

•     Thrombotic microangiopathy (TTP/HUS): rare but potentially fatal

•     Severe hypertension and hepatotoxicity

•     Significant pre-existing cardiac disease (heart failure, recent MI, severe arrhythmia) — use only with extreme caution and cardiology support

•     Pregnancy — CONTRAINDICATED: causes significant fetal harm

•     Note: Do NOT use in combination with melphalan + prednisone in transplant-ineligible newly diagnosed multiple myeloma patients (increased serious adverse events)

Pregnancy

CONTRAINDICATED. Must use effective contraception during treatment: females for at least 6 months after the last dose; males for at least 3 months after the last dose.

Breastfeeding

CONTRAINDICATED. Do not breastfeed during treatment or for 2 weeks after the final dose.

Cardiac Monitoring

Baseline cardiac assessment (echocardiogram or MUGA scan) is required before starting. Blood pressure must be monitored regularly throughout treatment. Cardiac complications from carfilzomib can be fatal.

Renal Monitoring

Monitor kidney function frequently. Adequate hydration before and after every dose is essential. Withhold carfilzomib if creatinine rises more than 2× baseline.

•     Anticoagulants: Thrombocytopenia increases bleeding risk — monitor INR and platelet counts closely

•     Antihypertensives: Carfilzomib can cause significant hypertension — blood pressure management may need adjustment

•     P-glycoprotein (P-gp) substrates: Carfilzomib is a P-gp substrate — strong P-gp inhibitors may increase exposure

•     Unopened vials: Store refrigerated at 2–8°C in original packaging. Remove from refrigerator just before use.

•     Reconstituted solution: Use within 1 hour at room temperature or within 24 hours if refrigerated

•     Single use only — discard any unused portion

POM — Prescription Only Medicine. Specialist oncologist/haematologist prescription required. Administered in a certified oncology/haematology unit only.

•     Attend all blood count checks before each cycle — your dose and timing depend on your results

•     Drink adequate fluids the day before, the day of, and the day after each infusion to protect your kidneys

•     Use effective contraception during treatment and for 6 months (females) or 3 months (males) after the last dose

•     Cardiac baseline: Echocardiogram and baseline ECG mandatory — LVEF <40% is a relative contraindication

•     Blood pressure monitoring: Check before and after every infusion; manage with standard antihypertensives as needed (avoid calcium channel blockers that extend QT)

•     Dexamethasone premedication: Reduces infusion reactions — essential in all Cycle 1 doses and reinstate after any infusion reaction

•     Hydration protocol: 250–500 mL IV saline pre- and post-infusion recommended; oral hydration (at least 1.5 L/day) throughout treatment

•     Carfilzomib vs bortezomib: Carfilzomib causes less peripheral neuropathy (irreversible binding spares peripheral nerves) but more cardiovascular toxicity — preferred in neuropathy-prone patients

•     Reconstitution: Do NOT shake — shake denatures the protein and creates foaming; gently swirl only

Q: How is carfilzomib different from bortezomib?

A: Both are proteasome inhibitors, but carfilzomib binds irreversibly to the proteasome (permanent binding per dose) while bortezomib binds reversibly. Carfilzomib generally causes significantly less peripheral neuropathy (nerve damage) than bortezomib, but has more cardiovascular effects. For patients who have developed nerve damage from previous bortezomib therapy, carfilzomib is often the preferred alternative.

Q: What warning signs of a serious infusion reaction should I watch for?

A: Report immediately to your oncology team if you experience any of the following during or up to 24 hours after your infusion: fever, chills, severe shortness of breath, swelling of the face or throat, chest pain, or feeling faint. These could be signs of a serious infusion reaction.

Q: Will I lose my hair with carfilzomib?

A: Hair loss is not a typical side effect of carfilzomib, unlike many traditional chemotherapy drugs. However, fatigue, reduced blood counts, and fluid retention are common. Your oncology team will monitor all of these throughout your treatment.