LORBRENA 25 MG

What is LORBRENA?

LORBRENA 25 MG contains LORLATINIB : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02485966, held by PFIZER CANADA ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 22-Apr-2019. 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 LORBRENA used for?

LORBRENA (lorlatinib) is indicated as: • monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) • monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib. The marketing authorization for the second and later line indication was based on a primary efficacy endpoint of tumor objective response rate and duration of response; no overall survival benefit has been demonstrated (see 14 CLINICAL TRIALS).

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 LORBRENA is 100 mg taken orally once daily continuously. Continue treatment with LORBRENA until disease progression or unacceptable toxicity. LORBRENA may be taken with or without food (see 10 CLINICAL PHARMACOLOGY). Pediatric patients (<18 years): The safety and efficacy of LORBRENA in pediatric patients have not been established. Health Canada has not authorized an indication for pediatric use. Geriatrics (≥ 65 years): No clinically important differences in safety or efficacy were observed between patients aged 65 years or older and younger patients (see 10 CLINICAL PHARMACOLOGY). Dose Modifications: Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. Dose reduction levels are summarized below. • First dose reduction: LORBRENA 75 mg taken orally once daily • Second dose reduction: LORBRENA 50 mg taken orally once daily LORBRENA should be permanently discontinued if the patient is unable to tolerate LORBRENA 50 mg taken orally once daily. Dose modification recommendations for toxicities are provided in Table 1. Dose modification recommendations for patients who develop first-degree, second-degree, or complete atrioventricular (AV) block are provided in Table 2. Administration: Patients should be encouraged to take their dose of LORBRENA at approximately the same time each day. Tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact. Missed Dose: If a dose of LORBRENA is missed, then it should be taken as soon as the patient remembers unless it is less than 4 hours before the next dose, in which case the patient should not take the missed dose. Patients should not take 2 doses at the same time to make up for a missed dose.

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 package to protect from light.

How is it supplied?

25 mg: high density polyethylene bottles containing 30, 60, or 100 tablets; aluminum foil blisters with aluminum foil backing containing 120 tablets (12 cards of 10 tablets)§ 100 mg: high density polyethylene bottles containing 30, 60, or 100 tablets; aluminum foil blisters with aluminum foil backing containing 30 tablets (3 cards of 10 tablets)§ § not commercially available in Canada

Contraindications

LORBRENA (lorlatinib) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Concomitant use of strong CYP3A inducers with LORBRENA is contraindicated due to the potential for serious hepatotoxicity (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] elevations (see 4 DOSAGE AND ADMINISTRATION and 9 DRUG INTERACTIONS).

Warnings and precautions

Serious Warnings and Precautions: • Hypercholesterolemia/Hypertriglyceridemia (see 7 WARNINGS AND PRECAUTIONS, Metabolism and Endocrine, Hyperlipidemia) • Pneumonitis (see 7 WARNINGS AND PRECAUTIONS, Respiratory, ILD/Pneumonitis) • Hepatotoxicity (see 7 WARNINGS AND PRECAUTIONS, General, Drug-Drug Interactions, Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers) LORBRENA should only be prescribed and supervised by a qualified physician experienced in the use of antineoplastic agents. Cardiovascular: Atrioventricular (AV) Block: PR interval prolongation and atrioventricular (AV) block events have been reported in patients receiving LORBRENA. For those patients who develop AV block, dose modification may be required. Hypertension: Hypertension can occur in patients receiving LORBRENA. Withhold and resume at a reduced dose or permanently discontinue LORBRENA based on severity. Driving and Operating Machinery: LORBRENA has moderate influence on the ability to drive and use machines. Caution should be exercised when driving or operating machines as patients may experience central nervous system effects. Endocrine and Metabolism: Hyperlipidemia: The use of LORBRENA has been associated with increases in serum cholesterol and triglycerides. Initiation, or increase in the dose, of lipid-lowering agents is recommended. Hyperglycemia: Hyperglycemia can occur in patients receiving LORBRENA. Withhold and resume at a reduced dose or permanently discontinue LORBRENA based on severity. Neurologic: Central Nervous System Effects: Central nervous system (CNS) effects have been observed in patients receiving LORBRENA. These include seizures, psychotic effects and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep. Dose modification may be required for those patients who develop CNS effects. Permanent discontinuation of LORBRENA is recommended in patients diagnosed with Grade 4 CNS effects. Respiratory: ILD/Pneumonitis: Severe or life-threatening pulmonary adverse reactions consistent with pneumonitis have occurred with LORBRENA. Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis. Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENA for treatment-related ILD/pneumonitis of any severity.

What can be used instead?

Other Canadian products sharing ATC code L01ED05 LORLATINIB. 2 of 2 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 LORLATINIB worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. LORLATINIB appears in 26 registered pack listings across 12 markets, published on 9 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.