IBRANCE 100 MG

What is IBRANCE?

IBRANCE 100 MG contains PALBOCICLIB : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02493543, held by PFIZER CANADA ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 21-Sep-2020. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is IBRANCE used for?

IBRANCE (palbociclib) is indicated for: the treatment of pre/perimenopausal or postmenopausal women, or men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant in patients with disease progression after prior endocrine therapy. Pre/perimenopausal women and men treated with the combination IBRANCE plus aromatase inhibitor therapy, and pre/perimenopausal women treated with the combination IBRANCE plus fulvestrant therapy should also be treated with a luteinizing hormone releasing hormone (LHRH) agonist. Clinical effectiveness of IBRANCE in combination with an aromatase inhibitor is based on the benefit observed in patients treated with IBRANCE in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

The recommended dose of IBRANCE (palbociclib) is a 125 mg-tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE is used in combination with an aromatase inhibitor or fulvestrant. For full dosing instructions of the selected aromatase inhibitor-or fulvestrant, please consult the corresponding Product Monographs. Management of some adverse reactions may require temporary dose interruptions/delays and/or dose reductions, or permanent discontinuation of IBRANCE as per dose reduction schedules provided in Table 1, 2, and 3. IBRANCE tablets may be taken with or without food. Patients should be advised to take their dose at approximately the same time each day. Continue the treatment as long as the patient is deriving clinical benefit from therapy. If the patient vomits or misses a dose, an additional dose should not be taken that day. The next prescribed dose should be taken at the usual time. IBRANCE tablets should be swallowed whole (do not chew, crush or split the tablets prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at 15 °C to 30°C in the original blister pack to protect from moisture. Keep out of reach and sight of children.

How is it supplied?

Box containing 3 weekly blister packs of 7 tablets each (21 tablets total) for 125 mg, 100 mg, and 75 mg strengths.

Contraindications

Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Do not use IBRANCE if you are allergic to palbociclib or any of the other ingredients of IBRANCE.

Warnings and precautions

IBRANCE (palbociclib) should be prescribed and managed by a qualified physician who is experienced in the use of anti-cancer agents. The following is a significant adverse drug reaction identified in clinical trials conducted with IBRANCE: Neutropenia. Permanently discontinue IBRANCE in patients with severe interstitial lung disease (ILD) or pneumonitis. IBRANCE may predispose patients to infections. Physicians should be aware of the increased risk of infection with IBRANCE and should inform patients to promptly report any episodes of fever. Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur in patients treated with IBRANCE when taken in combination with endocrine therapy. Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE immediately and evaluate the patient. IBRANCE should be permanently discontinued in patients diagnosed with severe drug-related ILD/pneumonitis. Across clinical trials, venous thromboembolic events (VTEs) were reported. Monitor patients for signs and symptoms of VTEs and treat as medically appropriate. No studies of the effects of IBRANCE (palbociclib) on the ability to drive or operate machinery have been conducted. However, since fatigue and dizziness have been reported with the use of IBRANCE, patients should exercise caution when driving or operating machinery while taking IBRANCE.

What can be used instead?

Other Canadian products sharing ATC code L01EF01 PALBOCICLIB. 9 of 12 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies PALBOCICLIB worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. PALBOCICLIB appears in 89 registered pack listings across 13 markets, published on 10 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.