WARNING

Docefrez is a medication used in chemotherapy to treat various types of cancer, including breast, lung, stomach, and prostate cancers. Like many chemotherapy drugs, it carries certain risks and potential side effects. Some common risks associated with Docefrez include:

• Bone marrow suppression: Docefrez can decrease the production of blood cells in the bone marrow, leading to anemia (low red blood cells), leukopenia (low white blood cells), and thrombocytopenia (low platelets).
• Infection: Due to decreased white blood cell count, patients taking Docefrez are at higher risk of developing infections.
• Nausea and vomiting: These are common side effects of many chemotherapy drugs, including Docefrez.
• Fatigue: Chemotherapy can cause significant tiredness and fatigue.
• Hair loss: Many chemotherapy drugs, including Docefrez, can cause hair loss or thinning.
• Neuropathy: Docefrez may cause nerve damage, leading to symptoms such as numbness, tingling, or weakness in the hands and feet.
• Allergic reactions: Some patients may experience allergic reactions to Docefrez, which can range from mild to severe.
• Fluid retention: Docefrez can cause fluid retention, leading to swelling in the legs, ankles, or other parts of the body.
• Pain at injection site: Pain or irritation at the injection site is a common side effect of Docefrez.

It’s important for patients to discuss these potential risks and side effects with their healthcare provider before starting treatment with Docefrez. Additionally, healthcare providers will closely monitor patients during treatment to manage any side effects that may arise.

Why is this medication prescribed?

Docefrez, a formulation of the chemotherapy drug docetaxel, is prescribed to treat various types of cancer. Its primary uses include:

• Breast Cancer: Often used in patients with advanced or metastatic breast cancer, particularly if the cancer has not responded to other treatments.
• Non-Small Cell Lung Cancer (NSCLC): Used as a treatment for advanced NSCLC, either alone or in combination with other chemotherapy drugs.
• Prostate Cancer: Used in combination with prednisone to treat metastatic castration-resistant prostate cancer.
• Gastric Cancer: Prescribed for advanced gastric adenocarcinoma, including cancer of the gastroesophageal junction, often in combination with other chemotherapy agents.
• Head and Neck Cancer: Used for the treatment of advanced squamous cell carcinoma of the head and neck.

How should this medicine be used?

Docefrez should be used under the supervision of a qualified healthcare professional experienced in the use of chemotherapy drugs. Here are general guidelines on how it should be used:

• Administration: Docefrez is administered as an intravenous (IV) infusion. The dosage and frequency depend on the type of cancer being treated, the patient’s overall health, and their response to the treatment.
• Dosage: The exact dosage is determined by the doctor based on factors like body surface area, cancer type, and treatment protocol. Dosages may need to be adjusted based on how well the patient tolerates the drug and side effects.
• Preparation: Before receiving Docefrez, patients are often given premedication, such as corticosteroids, to reduce the risk of allergic reactions and fluid retention.
• Treatment Cycle: Docefrez is typically given in cycles. A cycle may involve receiving the drug once every three weeks, although this can vary. The treatment plan will be tailored to the patient’s specific needs and medical condition.
• Monitoring: Patients will be closely monitored during treatment for side effects and response to therapy. Blood tests are frequently conducted to check blood cell counts and liver function.
• Side Effect Management: If severe side effects occur, the healthcare provider may adjust the dosage or delay treatment. Supportive care medications may be provided to manage side effects such as nausea, vomiting, and infections.

Patients should follow their healthcare provider’s instructions closely and report any side effects or concerns immediately. Regular follow-up appointments are essential to monitor the effectiveness of the treatment and manage any potential side effects.

Other uses for this medicine

While primarily used for various cancers (breast, lung, prostate, stomach, head, and neck cancers), Docefrez is sometimes used off-label for other conditions based on the oncologist’s discretion. Off-label use means using the medication for conditions not specifically listed in the official prescribing information.

What special precautions should I follow?

When using Docefrez, it is crucial to follow specific precautions to minimize risks and manage potential side effects effectively:

• Allergies: Inform your doctor if you have any allergies, especially to docetaxel or any other medications, or if you have had severe allergic reactions to other chemotherapy drugs.
• Medical History: Provide a complete medical history, particularly if you have:
  • Liver disease
  • Heart problems
  • Infections
  • Fluid retention
  • Blood disorders (e.g., anemia, neutropenia)
• Pregnancy and Breastfeeding: Docefrez can harm an unborn baby, so it should not be used during pregnancy. Effective contraception should be used during treatment and for some time afterward. Breastfeeding is also not recommended during treatment.
• Medications: Inform your doctor about all medications, supplements, and herbal products you are taking, as some can interact with Docefrez and affect its efficacy or increase side effects.
• Pre-Treatment Medications: You may need to take corticosteroids before starting Docefrez to reduce the risk of fluid retention and allergic reactions. Follow your doctor’s instructions regarding these medications closely.
• Monitoring: Regular blood tests are necessary to monitor blood cell counts, liver function, and overall health. Attend all scheduled appointments and promptly report any unusual symptoms or side effects.
• Infection Risk: Due to the risk of reduced white blood cell counts, avoid contact with people who are sick, practice good hygiene, and report any signs of infection (e.g., fever, chills, sore throat) immediately.
• Avoid Vaccinations: Do not receive any vaccinations without your doctor’s approval, as your immune system may be weakened during treatment.
• Diet and Lifestyle: Maintain a healthy diet and stay hydrated. Follow any specific dietary recommendations from your healthcare team. Avoid alcohol as it can increase the risk of liver problems and dehydration.
• Driving and Operating Machinery: Docefrez can cause dizziness or fatigue, so be cautious when driving or operating heavy machinery until you know how the medication affects you.

By adhering to these precautions and maintaining open communication with your healthcare team, you can help manage the risks associated with Docefrez and ensure the best possible outcome from your treatment.

What special dietary instructions should I follow?

• General Diet: There are no specific dietary restrictions for Docefrez. However, maintaining a balanced and nutritious diet is important to support your overall health and immune system during chemotherapy.
• Hydration: Drink plenty of fluids to stay well-hydrated, which can help your body manage the side effects of chemotherapy.
• Managing Side Effects: If you experience nausea or mouth sores, your healthcare team may recommend specific dietary adjustments, such as eating bland, soft foods and avoiding spicy or acidic foods.

What should I do if I forget a dose?

• If you miss a dose of Docefrez, contact your healthcare provider immediately. Do not attempt to make up the missed dose on your own.
• Your doctor will provide instructions on how to proceed, which may involve rescheduling the missed dose or adjusting your treatment schedule.

What side effects can this medication cause?

Docefrez is a chemotherapy medication primarily used to treat various types of cancer, including breast, lung, stomach, and prostate cancers. Like many chemotherapy drugs, Docefrez can cause a range of side effects. Some common side effects include:

• Nausea and vomiting: These are common side effects of many chemotherapy drugs. Medications can often help manage these symptoms.
• Hair loss: Chemotherapy drugs like Docefrez can cause hair loss, though the extent varies from person to person.
• Fatigue: Feeling tired or fatigued is a common side effect of chemotherapy.
• Low blood cell counts: Chemotherapy can lower the number of white blood cells, which can increase the risk of infection, and red blood cells, which can lead to anemia. Platelet counts may also decrease, affecting blood clotting.
• Peripheral neuropathy: This condition causes tingling, numbness, and pain in the hands and feet.
• Mouth sores: Chemotherapy drugs can irritate the lining of the mouth and throat, leading to sores or mouth ulcers.
• Loss of appetite: Some people may experience a decreased appetite or changes in taste during chemotherapy treatment.
• Allergic reactions: Although rare, some people may experience allergic reactions to Docefrez, which can include rash, itching, difficulty breathing, or swelling of the face, lips, or throat.
• Muscle and joint pain: Chemotherapy can cause muscle and joint pain or stiffness.
• Constipation or diarrhea: Changes in bowel habits are common during chemotherapy treatment.

It’s important to note that not everyone will experience all of these side effects, and the severity can vary from person to person. Additionally, there may be other side effects not listed here, so it’s essential for patients to discuss potential side effects with their healthcare provider before starting treatment.

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

Storage and Disposal of Docefrez

Storage:

• Temperature: Store Docefrez vials at a controlled room temperature between 20°C to 25°C (68°F to 77°F). Brief excursions are permitted between 15°C to 30°C (59°F to 86°F).
• Protection: Protect from light. Keep the vials in their original cartons until ready for use.
• Preparation: Once diluted for infusion, the solution should be used within specified time frames and conditions as indicated by the healthcare provider or manufacturer’s instructions.

Disposal:

• Unused Medication: Do not dispose of unused Docefrez in household trash or down the sink or toilet. Follow local regulations for hazardous waste disposal.
• Sharps: Use an appropriate sharps container for disposal of needles and syringes. Do not reuse needles or syringes.
• Professional Guidance: Consult with a pharmacist or healthcare provider for guidance on the proper disposal methods in your area.

In case of emergency/overdose

• Symptoms: Overdose symptoms may include severe neutropenia, severe mucositis, severe diarrhea, or other life-threatening toxicities.
• Immediate Action: Seek emergency medical attention immediately. Call 911 or your local emergency number.
• Hospital Care: Overdose typically requires hospitalization for intensive supportive care, including possible administration of colony-stimulating factors to manage neutropenia, antibiotics for infection, and symptomatic treatment for other side effects.

What other information should I know?

• Pre-medications: Patients are often given pre-medications such as corticosteroids (e.g., dexamethasone) to minimize the risk of hypersensitivity reactions and fluid retention.
• Blood Tests: Regular blood tests are required to monitor blood cell counts and liver function.
• Infection Risk: Due to the risk of low white blood cell counts, patients should avoid contact with sick individuals and practice good hygiene.
• Interactions: Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as Docefrez can interact with other substances.
• Pregnancy and Breastfeeding: Docefrez can harm an unborn baby. Women should not become pregnant while using this medication and should use effective contraception. It is not known if Docefrez passes into breast milk, so breastfeeding is not recommended.
• Side Effects Management: Discuss with your healthcare provider ways to manage common side effects such as nausea, hair loss, and peripheral neuropathy.
• Follow-Up: Regular follow-up appointments are necessary to monitor your response to treatment and manage any side effects.

Always follow your healthcare provider’s instructions and guidelines when using Docefrez. If you have any concerns or questions, do not hesitate to contact your healthcare provider.