Lenalidomide

lenalidomide

Brand(s):

• Lenalid

Manufacturer:

• Natco Pharma Limited

Disease(s):

• Tumor Growth / Anemia / Multiple Myeloma / Cell Lymphoma

Lenalidomide Capsules

What is Lenalidomide?

Lenalidomide is a medication that works by influencing the immune system. It boosts immune responses to help slow down tumor growth. It's used to treat several conditions, including:

• Anemia: A deficiency of red blood cells.
• Multiple Myeloma: A cancer stemming from a progressive blood disease.
• Mantle Cell Lymphoma: A rare cancer affecting the lymph nodes.
• Myelodysplastic Syndrome (MDS) with deletion 5q: A disorder where the bone marrow doesn't produce enough healthy blood cells, specifically the type caused by a missing part of chromosome 5.

It's crucial to note that lenalidomide shouldn't be used for chronic lymphocytic leukemia (CLL) except within controlled medical studies, as it may increase the risk of death from serious heart problems in CLL patients.

Lenalidomide may also have off-label uses not detailed here.

Important Safety Information

Never use lenalidomide if you are pregnant or might become pregnant. It can cause severe, life-threatening birth defects. Before starting treatment, a negative pregnancy test is mandatory, and you'll need to use two reliable forms of birth control throughout the treatment period and for a specified time afterward.

Lenalidomide is dispensed only through certified pharmacies under a specialized program. You must be registered in this program and fully understand the associated risks.

This medication can lower the blood cell count, increasing susceptibility to infections and bleeding. Contact your doctor immediately if you experience unusual bruising or bleeding, or signs of infection (fever, chills, body aches). Regular blood tests are necessary during treatment.

Lenalidomide might increase the risk of blood clots, especially when combined with dexamethasone. Seek immediate medical attention if you experience signs of a blood clot such as chest pain, sudden cough, wheezing, rapid breathing, coughing up blood, or pain, swelling, warmth, or redness in an arm or leg.

Before Taking Lenalidomide

Do not use lenalidomide if you are allergic to it.

Lenalidomide poses a severe risk of life-threatening birth defects or death of a baby if taken by either parent around the time of conception or during pregnancy. Even a single dose can cause major birth defects. Absolutely avoid use during pregnancy. Report any late periods immediately to your doctor.

For Women:

Unless you've had a hysterectomy or have been in menopause for at least 24 consecutive months, you must use two reliable birth control methods. This starts 4 weeks before treatment, continues throughout, and ends 4 weeks after stopping. Even women with fertility issues must use contraception. Pregnancy tests are required 10 to 14 days before treatment, 24 hours before starting, and every 4 weeks during treatment.

Highly effective methods include birth control pills, an IUD, tubal ligation, or a vasectomy of your partner. An additional barrier method (latex condom, diaphragm, cervical cap) is also required.

Stop taking lenalidomide and contact your doctor immediately if you stop using birth control, if your period is late, or if you suspect pregnancy.

For Men:

Avoid causing a pregnancy while taking lenalidomide. It can affect sperm and lead to birth defects. You must agree to always use condoms during sex with women who can become pregnant, even if you have had a vasectomy. Contact your doctor immediately if you have unprotected sex or suspect your partner is pregnant.

Lenalidomide is available only through a specialized program. You must register and acknowledge the risks, agreeing to the birth control requirements. Prescriptions are typically limited to a 28-day supply.

For patients aged 12-18, a parent or guardian must read and sign all program requirements.

Inform your doctor if you have:

• Kidney disease
• Liver disease
• History of blood clots or stroke
• Lactose intolerance
• History of allergic reaction to thalidomide

Lenalidomide may increase the risk of other cancers, such as leukemia or lymphoma. Discuss your individual risk with your doctor.

It's unknown if lenalidomide passes into breast milk. Breastfeeding is not recommended while using this medicine.

How to Take Lenalidomide

Take lenalidomide precisely as prescribed. Follow all instructions on your prescription label. Your doctor may adjust your dose. Never alter the dose or duration without consulting your doctor.

Follow the patient instructions carefully. Never share this medication.

Lenalidomide can be taken with or without food, but maintain consistency.

Take each dose with a full glass of water. Swallow the capsule whole; do not break it open.

Lenalidomide can lower blood cells, increasing infection and bleeding risks. Regular blood tests are crucial. Visit your doctor regularly.

Avoid skin contact with the contents of a broken capsule. Wash skin thoroughly with soap and water if contact occurs. Ask your doctor or pharmacist for safe handling and disposal instructions for broken capsules.

Store at room temperature, away from moisture and heat.

Read all provided information and ask questions if needed.

Lenalidomide Dosage Information

Dosage varies depending on the condition being treated. Always follow your doctor's specific instructions.

Usual Adult Dose for Myelodysplastic Diseases:

10 mg orally once daily

Approved indication: Treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality, with or without additional cytogenetic abnormalities.

Usual Adult Dose for Multiple Myeloma:

25 mg/day orally (single 25 mg capsule) on days 1 through 21 of repeated 28-day cycles.

(Dexamethasone may be co-administered; consult your doctor for specific instructions.)

The effects of using lower-strength capsules to achieve a 25 mg total dose are unknown.

Usual Adult Dose for Lymphoma:

25 mg orally once daily on days 1 to 21 of repeated 28-day cycles.

Duration of therapy: Treatment typically continues until disease progression or unacceptable toxicity.

Approved indication: Treatment of mantle cell lymphoma (MCL) in patients whose disease has relapsed or progressed after two prior therapies, one including bortezomib.

Missed Dose

Take the missed dose as soon as you remember, unless more than 12 hours have passed. Do not double the dose.

Overdose

Seek immediate medical attention or call a poison control center.

What to Avoid While Taking Lenalidomide

Do not donate blood or sperm during treatment and for 4 weeks afterward.

Lenalidomide can be present in body fluids. Caregivers should wear gloves when handling body fluids, contaminated waste, or laundry. Wash hands thoroughly before and after glove use. Wash soiled clothing and linens separately.

Lenalidomide Side Effects

Seek immediate medical help for allergic reactions: hives, difficulty breathing, facial/lip/tongue/throat swelling.

Contact your doctor immediately if you experience:

• Fever, swollen gums, mouth sores, difficulty swallowing, skin sores, cold/flu symptoms, cough, breathing problems
• Easy bruising, unusual bleeding, pinpoint red/purple spots under skin
• Blood clot signs: chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; arm/leg pain, swelling, warmth, or redness
• Liver problems: nausea, upper stomach pain, itching, fatigue, loss of appetite, dark urine, clay-colored stools, jaundice
• Tumor cell breakdown signs: lower back pain, blood in urine, reduced urination; numbness/tingling around mouth; muscle weakness/tightness; fast/slow heart rate, weak pulse, shortness of breath; confusion, fainting
• Signs of worsening tumor: swollen glands, low fever, rash, pain

Common side effects may include itching, rash, diarrhea, and fatigue.

This is not an exhaustive list. Consult your doctor about side effects. Report side effects to the appropriate regulatory authority.

Drug Interactions

Lenalidomide can interact with other drugs, including over-the-counter medications and supplements. Inform all healthcare providers of all medications you are taking.

Keep this and all medications out of reach of children. Never share your medication.