WARNING

Daunorubicin and Cytarabine Lipid Complex Injection (CPX-351) carries several risks, including:

• Bone Marrow Suppression: CPX-351 can decrease blood cell production, leading to anemia, increased susceptibility to infections, and bleeding.
• Cardiotoxicity: It may harm heart function, leading to heart rhythm disturbances or decreased heart function.
• Gastrointestinal Effects: Nausea, vomiting, diarrhea, and mouth sores are common side effects.
• Liver and Kidney Toxicity: CPX-351 can affect liver and kidney function, causing changes in enzyme levels or kidney function tests.
• Increased Infection Risk: Suppressing the immune system can raise the risk of infections.
• Hair Loss: Temporary hair loss or thinning may occur.
• Other Side Effects: Fatigue, decreased appetite, and taste changes are possible.

Patients should discuss these risks with their healthcare provider and be monitored closely during treatment.

Why is this medication prescribed?

Daunorubicin and Cytarabine Lipid Complex Injection, is a medication used in the treatment of certain types of acute myeloid leukemia (AML), a cancer of the blood and bone marrow. It’s specifically indicated for adults with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes.

The combination of daunorubicin and cytarabine in a lipid complex formulation enhances the delivery of these chemotherapy agents to leukemia cells while minimizing exposure to normal tissues, potentially improving efficacy and reducing toxicity.

How should this medicine be used?

As for how it’s used, CPX-351 is typically administered by a healthcare professional through intravenous infusion. The dosage and schedule may vary depending on individual patient factors such as age, overall health, and the specific type and stage of leukemia being treated. It’s essential to follow your doctor’s instructions carefully regarding dosing and administration.

Treatment with CPX-351 may involve multiple cycles of therapy, with each cycle typically lasting for several days. Your doctor will monitor your response to treatment and adjust the dosage or schedule as needed to manage side effects and optimize therapeutic outcomes.

It’s crucial to discuss any questions or concerns about CPX-351 treatment with your healthcare provider, including potential side effects and precautions to take during therapy.

Other uses for this medicine

Daunorubicin and Cytarabine Lipid Complex Injection (CPX-351) is primarily used for the treatment of certain types of acute myeloid leukemia (AML), as previously mentioned. However, its use may extend beyond this primary indication in some cases, as determined by healthcare providers. Some off-label uses or investigational uses of CPX-351 may exist, but these would be determined on a case-by-case basis by physicians and may not be standard practice.

What special precautions should I follow?

As for special precautions to consider when using Daunorubicin and Cytarabine Lipid Complex Injection:

• Medical History: Before starting treatment with CPX-351, it’s important to provide your healthcare provider with a comprehensive medical history, including any previous chemotherapy or radiation therapy, presence of other medical conditions, and any known allergies or sensitivities to medications.
• Pregnancy and Breastfeeding: CPX-351 can cause harm to a developing fetus, so it’s crucial to discuss pregnancy plans and contraceptive measures with your doctor before starting treatment. Additionally, breastfeeding is not recommended during CPX-351 therapy due to the potential for harm to the nursing infant.
• Bone Marrow Suppression: CPX-351 can suppress bone marrow function, leading to decreased production of blood cells (red blood cells, white blood cells, and platelets). Your doctor will monitor your blood cell counts regularly during treatment and may adjust your dosage or schedule as needed to manage this side effect.
• Cardiotoxicity: Daunorubicin, one of the components of CPX-351, can have toxic effects on the heart. Your healthcare provider will monitor your heart function closely during treatment, and if any signs of cardiotoxicity develop, treatment may be adjusted or discontinued.
• Liver and Kidney Function: CPX-351 may affect liver and kidney function. Your doctor may perform blood tests to monitor these organ functions during treatment.
• Infections: CPX-351 can increase the risk of infections due to its effects on the immune system. It’s important to promptly report any signs or symptoms of infection to your healthcare provider during treatment.
• Hypersensitivity Reactions: Individuals with a history of hypersensitivity or allergic reactions to any of the components of CPX-351 should not receive this medication.
• Other Medications and Supplements: It’s important to inform your healthcare provider about all medications, supplements, and herbal products you are taking before starting CPX-351 treatment, as some medications may interact with CPX-351 and affect its efficacy or safety.

Always follow your healthcare provider’s instructions and guidance regarding the use of Daunorubicin and Cytarabine Lipid Complex Injection, and don’t hesitate to ask any questions or raise any concerns you may have about your treatment plan.

What special dietary instructions should I follow?

Regarding special dietary instructions for CPX-351, there are no specific dietary restrictions associated with its use. However, it’s essential to maintain a well-balanced diet to support your overall health and immune function during cancer treatment. Your healthcare provider or a registered dietitian can provide personalized dietary recommendations based on your individual needs and medical condition.

What should I do if I forget a dose?

If you forget a dose of CPX-351, contact your healthcare provider or treatment team for guidance. It’s important to follow their instructions carefully, as missing a dose or delaying treatment may affect the effectiveness of your therapy. They will advise you on the best course of action based on your specific situation, which may include rescheduling the missed dose or adjusting your treatment plan accordingly. Never try to compensate for a missed dose by taking extra medication without consulting your healthcare provider first

What side effects can this medication cause?

Daunorubicin and Cytarabine Lipid Complex Injection (CPX-351) can cause a range of side effects, some of which may be serious. It’s important to be aware of these potential side effects and to discuss them with your healthcare provider before starting treatment. Common side effects of CPX-351 may include:

• Bone Marrow Suppression: CPX-351 can lead to a decrease in blood cell counts, including red blood cells (anemia), white blood cells (neutropenia), and platelets (thrombocytopenia). This can increase the risk of infections, bleeding, and fatigue.
• Nausea and Vomiting: Gastrointestinal side effects such as nausea, vomiting, and diarrhea are common with CPX-351 treatment. Your healthcare provider may prescribe medications to help manage these symptoms.
• Fatigue: Feeling tired or fatigued is a common side effect of CPX-351 treatment, often related to anemia or the overall impact of cancer therapy on the body.
• Mouth Sores: Some individuals may experience mouth sores or mucositis (inflammation of the mucous membranes in the mouth and throat) as a side effect of CPX-351 treatment.
• Hair Loss: CPX-351 can cause temporary hair loss or thinning, although this side effect is usually reversible once treatment is completed.
• Decreased Appetite: Some people may experience a decreased appetite or changes in taste during CPX-351 therapy.
• Liver Toxicity: CPX-351 can affect liver function, leading to elevated liver enzymes in blood tests. Your healthcare provider will monitor your liver function regularly during treatment.
• Kidney Toxicity: CPX-351 may also affect kidney function, resulting in changes in urine output or kidney function tests.
• Cardiotoxicity: Daunorubicin, one of the components of CPX-351, can have toxic effects on the heart, leading to decreased heart function or heart rhythm disturbances. Your doctor will monitor your heart function closely during treatment.
• Infections: CPX-351 can increase the risk of infections due to its effects on the immune system and bone marrow suppression.

It’s important to report any side effects or symptoms you experience during CPX-351 treatment to your healthcare provider promptly. They can provide guidance on managing side effects and may adjust your treatment plan as needed to improve your comfort and safety.

What should I know about storage and disposal of this medication?

For storage and disposal of Daunorubicin and Cytarabine Lipid Complex Injection (CPX-351):

• Storage: CPX-351 should be stored in its original packaging at controlled room temperature, typically between 20°C to 25°C (68°F to 77°F). Avoid freezing or exposing the medication to excessive heat or light. Follow any specific storage instructions provided by your pharmacist or healthcare provider.
• Disposal: CPX-351 is administered by healthcare professionals in a clinical setting, so you won’t be responsible for its disposal. Any unused medication or empty vials should be disposed of according to local regulations for handling hazardous waste materials. Your healthcare provider or treatment facility will handle the proper disposal of CPX-351 and any associated medical waste.

In case of emergency/overdose

• Seek Medical Attention: If you suspect an overdose or experience severe adverse reactions after receiving CPX-351, seek immediate medical assistance. Contact your healthcare provider, go to the nearest emergency room, or call emergency services for help.
• Symptom Management: Depending on the nature and severity of the overdose or adverse reaction, medical professionals will provide appropriate supportive care and symptomatic treatment to manage symptoms and minimize complications. This may include measures such as supportive care, monitoring vital signs, administering medications to counteract toxic effects, and providing fluids and electrolytes as needed.

What other information should I know?

• Compliance: It’s essential to adhere to your prescribed treatment schedule and follow all instructions provided by your healthcare provider regarding CPX-351 therapy. Skipping doses or altering the treatment plan without medical supervision can compromise the effectiveness of treatment and may increase the risk of complications.
• Follow-up Care: Attend all scheduled follow-up appointments with your healthcare provider for monitoring and assessment of your response to CPX-351 treatment. Your doctor will evaluate your progress, monitor for potential side effects or complications, and make any necessary adjustments to your treatment plan.
• Supportive Care: Cancer treatment, including CPX-351, can be physically and emotionally challenging. Seek support from healthcare professionals, support groups, family, and friends to help cope with the demands of treatment and maintain overall well-being.
• Precautions: During CPX-351 treatment, take precautions to minimize the risk of infection, injury, and other complications. Follow your healthcare provider’s recommendations regarding infection prevention, dietary guidelines, and activity restrictions.

By staying informed and actively participating in your treatment plan, you can optimize the benefits of Daunorubicin and Cytarabine Lipid Complex Injection while minimizing risks and maximizing your overall quality of life during cancer therapy.