Lenalidomide (Page 10 of 12)

15 REFERENCES

1. OSHA Hazardous Drugs. OSHA [Accessed on 29 January 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Lenalidomide capsules are available as follows:

5 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “5mg” on body in black ink contains 5 mg of lenalidomide.

5 mg bottles of 28 (NDC 0480‐1242‐28)

10 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “10mg” on body in black ink contains 10 mg of lenalidomide.

10 mg bottles of 28 (NDC 0480‐1243‐28)

15 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “15mg” on body in black ink contains 15 mg of lenalidomide.

15 mg bottles of 21 (NDC 0480‐1244‐21)

25 mg – Each size 2 capsule with white cap and body printed with “NAT” on cap and “25mg” on body in black ink contains 25 mg of lenalidomide.

25 mg bottles of 21 (NDC 0480‐1246‐21)

16.2 Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

16.3 Handling and Disposal

Care should be exercised in the handling of lenalidomide capsules. Lenalidomide capsules should not be opened or broken. If powder from lenalidomide capsules contacts the skin, wash the skin immediately and thoroughly with soap and water. If lenalidomide contacts the mucous membranes, flush thoroughly with water.

Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.¹

Dispense no more than a 28-day supply.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved Patient labeling (Medication Guide)

Embryo-Fetal Toxicity

Advise patients that lenalidomide capsules are contraindicated in pregnancy [see Boxed Warning and Contraindications (4.1)]. Lenalidomide is a thalidomide analogue and can cause serious birth defects or death to a developing baby [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

• Advise females of reproductive potential that they must avoid pregnancy while taking lenalidomide capsules and for at least 4 weeks after completing therapy.
• Initiate lenalidomide capsules treatment in females of reproductive potential only following a negative pregnancy test.
• Advise females of reproductive potential of the importance of monthly pregnancy tests and the need to use 2 different forms of contraception including at least 1 highly effective form, simultaneously during lenalidomide capsules therapy, during dose interruption and for 4 weeks after she has completely finished taking lenalidomide capsules. Highly effective forms of contraception other than tubal ligation include IUD and hormonal (birth control pills, injections, patch or implants) and a partner’s vasectomy. Additional effective contraceptive methods include latex or synthetic condom, diaphragm and cervical cap.
• Instruct patient to immediately stop taking lenalidomide capsules and contact her healthcare provider if she becomes pregnant while taking this drug, if she misses her menstrual period, or experiences unusual menstrual bleeding, if she stops taking birth control, or if she thinks FOR ANY REASON that she may be pregnant.
• Advise patient that if her healthcare provider is not available, she should call the REMS Call Center at
  1‐888‐423‐5436 [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)].
• Advise males to always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide capsules and for up to 4 weeks after discontinuing lenalidomide capsules, even if they have undergone a successful vasectomy.
• Advise male patients taking lenalidomide capsules that they must not donate sperm and for up to 4 weeks after discontinuation of lenalidomide capsules [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)].
• All patients must be instructed to not donate blood while taking lenalidomide capsules, during dose interruptions and for 4 weeks following discontinuation of lenalidomide capsules [see Warnings and Precautions (5.1)].

Lenalidomide REMS program

Because of the risk of embryo-fetal toxicity, lenalidomide capsules are only available through a restricted program called the Lenalidomide REMS program [see Warnings and Precautions (5.2)].

• Patients must sign a Patient-Physician agreement form and comply with the requirements to receive lenalidomide capsules. In particular, females of reproductive potential must comply with the pregnancy testing, contraception requirements and participate in monthly telephone surveys. Males must comply with the contraception requirements [see Use in Specific Populations (8.3)].
• Lenalidomide capsules are available only from pharmacies that are certified in Lenalidomide REMS program. Provide patients with the telephone number and website for information on how to obtain the product.

Pregnancy Exposure Registry

Inform females there is a Pregnancy Exposure Registry that monitors pregnancy outcomes in females exposed to lenalidomide capsules during pregnancy and that they can contact the Pregnancy Exposure Registry by calling 1‐888‐423‐5436 [see Use in Specific Populations (8.1)].

Hematologic Toxicity

Inform patients that lenalidomide capsules are associated with significant neutropenia and thrombocytopenia [see Boxed Warning and Warnings and Precautions (5.3)].

Venous and Arterial Thromboembolism

Inform patients of the risk of thrombosis including DVT, PE, MI, and stroke and to report immediately any signs and symptoms suggestive of these events for evaluation [see Boxed Warning and Warnings and Precautions (5.4)].

Increased Mortality in Patients with CLL

Inform patients that lenalidomide capsules had increased mortality in patients with CLL and serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure [see Warnings and Precautions (5.5)].

Second Primary Malignancies

Inform patients of the potential risk of developing second primary malignancies during treatment with lenalidomide capsules [see Warnings and Precautions (5.6)].

Hepatotoxicity

Inform patients of the risk of hepatotoxicity, including hepatic failure and death, and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.8)].

Severe Cutaneous Reactions

Inform patients of the potential risk for severe skin reactions such as SJS, TEN, and DRESS and report any signs and symptoms associated with these reactions to their healthcare provider for evaluation. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive lenalidomide capsules [see Warnings and Precautions (5.9)].

Tumor Lysis Syndrome

Inform patients of the potential risk of tumor lysis syndrome and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.10)].

Tumor Flare Reaction

Inform patients of the potential risk of tumor flare reaction and to report any signs and symptoms associated with this event to their healthcare provider for evaluation [see Warnings and Precautions (5.11)].

Early Mortality in Patients with MCL

Inform patients with MCL of the potential for early death [see Warnings and Precautions (5.14)].

Hypersensitivity

Inform patients of the potential for severe hypersensitivity reactions such as angioedema and anaphylaxis to lenalidomide capsules. Instruct patients to contact their healthcare provider right away for signs and symptoms of these reactions. Advise patients to seek emergency medical attention for signs or symptoms of severe hypersensitivity reactions [see Warnings and Precautions (5.15)].

Dosing Instructions

Inform patients how to take lenalidomide capsules [see Dosage and Administration (2)]

• Lenalidomide capsules should be taken once daily at about the same time each day,
• Lenalidomide capsules may be taken either with or without food.
• The capsules should not be opened, broken, or chewed. Lenalidomide capsules should be swallowed whole with water.
• Instruct patients that if they miss a dose of lenalidomide capsules, they may still take it up to 12 hours after the time they would normally take it. If more than 12 hours have elapsed, they should be instructed to skip the dose for that day. The next day, they should take lenalidomide capsules at the usual time. Warn patients to not take 2 doses to make up for the one that they missed.

Manufactured In India By:
Natco Pharma Limited
Kothur — 509 228, India

OR

Manufactured In India By:
Natco Pharma Limited
Visakhapatnam ‐ 531019, AP, India

Manufactured For:
Teva Pharmaceuticals
Parsippany, NJ 07054

Rev. A 5/2022