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Pomalidomide Safety Information and Warnings:

Pomalidomide is a medication with significant risks and strict usage guidelines. It is important to follow these instructions carefully to ensure safety and effectiveness.

• Potential Harm to Unborn Babies: Pomalidomide can cause severe birth defects or even death in unborn babies. If you are a woman capable of becoming pregnant, you must either abstain from heterosexual intercourse or use two reliable forms of birth control starting four weeks before beginning treatment, continuing throughout the treatment period, and for four weeks after the last dose. Additionally, two negative pregnancy tests are required before starting treatment: one 10 to 14 days before and another within 24 hours of the first dose. Ongoing pregnancy tests are mandatory during treatment. If you become pregnant or suspect pregnancy, discontinue the medication immediately and notify your healthcare provider.

• Men's Contraception Requirements: Men using pomalidomide must use latex or synthetic condoms during sexual contact with female partners, even if they've had a vasectomy. This precaution should be maintained throughout treatment, during breaks, and for at least four weeks after stopping the medication. If a partner becomes pregnant or suspects pregnancy, inform your doctor immediately.

• REMS Program Compliance: In the United States, pomalidomide is only available through a restricted distribution program called the REMS Program. Patients must understand and agree to follow the program's requirements, which include signing a Patient-Physician Agreement Form and adhering to specific conditions, such as pregnancy testing and contraception compliance. Consult your healthcare provider for country-specific regulations if outside the United States.

• Blood Clots and Cardiovascular Risks: Pomalidomide may increase the risk of serious blood clots, which can lead to heart attacks, strokes, or pulmonary embolism. Seek immediate medical attention if you experience symptoms such as chest pain, sudden vision changes, or difficulty breathing. Your doctor may prescribe medications like aspirin or warfarin to mitigate these risks.

• Blood Cell Count Monitoring: This medication can lower your white and red blood cell counts and platelets, increasing the risk of anemia, bleeding, bruising, and infections. Regular blood tests will monitor your cell counts. Contact your healthcare provider if you experience fever, unusual bruising, or signs of infection.

• Liver Function Monitoring: Pomalidomide may cause liver damage, potentially leading to liver failure. Your healthcare provider will regularly check your liver function. Report symptoms such as fatigue, loss of appetite, nausea, or jaundice promptly.

• Serious Skin Reactions: Severe skin reactions, including Stevens-Johnson syndrome, may occur. If you develop painful blisters, sores, or skin peeling, seek immediate medical care.

• Nerve Damage: Be aware of symptoms indicating nerve damage, such as tingling, numbness, or burning sensations in the extremities. Report these symptoms to your provider for appropriate evaluation and management.

• Dizziness and Confusion: Pomalidomide can cause dizziness or confusion, especially if combined with alcohol or other similar medications. Avoid activities requiring alertness, such as driving, until you know how the medication affects you.

• Risk of New Cancers: Although rare, there is an increased risk of developing new cancers, including acute myeloid leukemia, when taking pomalidomide. Discuss these risks with your healthcare provider.

• Tumor Lysis Syndrome: Patients with a high tumor burden may be at risk for tumor lysis syndrome. Discuss your risk with your healthcare provider.

Contraindications:

• Pomalidomide should not be used if you are currently pregnant. Always consult your healthcare provider if you have concerns or conditions that may contraindicate use.

When using this medication, common side effects may include tiredness, weakness, constipation, diarrhea, nausea, back pain, and respiratory symptoms like a runny nose or sore throat. It is important to consult your healthcare provider if these persist or worsen. Low blood cell counts, affecting red and white cells as well as platelets, are also common, potentially leading to anemia or increased risk of infections.

More serious side effects, though less common, require prompt medical attention. These include symptoms such as fever, muscle or bone pain, decreased appetite, dizziness, and trouble breathing. The medication can also cause swelling in the hands and feet, headaches, high blood calcium levels, and nerve pain.

This medication may also impact kidney and liver function, as indicated by abnormal lab results, and alter blood sugar, phosphate, and calcium levels. In rare cases, serious complications like progressive multifocal leukoencephalopathy (PML), a severe brain infection, or liver disease may occur. Signs of these severe issues include sudden changes in coordination, memory, or speech, severe abdominal pain, persistent vomiting, dark urine, and yellowing of the skin or eyes.

Very rarely, this medication may increase the risk of other cancers or cause an allergic reaction. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice any unusual symptoms, it's crucial to contact your healthcare provider immediately.

When using Pomalyst (pomalidomide), it is important to inform your doctor and pharmacist about any other medications or supplements you are taking, including prescription, over-the-counter medications, vitamins, and herbal products. Interactions can occur with several substances. For instance, the use of alcohol, marijuana, antihistamines like diphenhydramine, sleep and anxiety medications such as alprazolam and zolpidem, muscle relaxants, and opioid pain relievers like codeine may increase dizziness or confusion. Smoking can also affect the levels of this medication in your blood, so it's crucial to notify your doctor if you smoke or have recently quit.

Additionally, certain medications like Abametapir, Ciprofloxacin, Enoxacin, Fluvoxamine, and Pixantrone may interact with Pomalyst. Although these combinations are generally not recommended, your doctor might adjust the dosage or frequency if both are necessary for your treatment. Always consult your healthcare provider to ensure safe and effective use of your medications.