Docefrez

Docefrez is a prescription medication used to treat certain types of breast, lung, and prostate cancers.  It may be used alone or in combination with other medicines. Docefrez belongs to a group of drugs called taxanes, which stop the growth and spread of cancer cells.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider, once every 3 weeks.

Common side effects of Docefrez include changes in taste, anemia, nausea, vomiting, and hair loss.

Docefrez is a prescription anti-cancer medicine used to treat certain people with:

• breast cancer: for locally advanced or advanced (metastatic) after chemotherapy has failed 
• non-small cell lung cancer (NSCLC)
  • for locally advanced or advanced (metastatic) after platinum therapy has failed
  • with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC 
• prostate cancer: with prednisone in androgen independent (hormone refractory) metastatic prostate cancer

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sun Pharma Global FZE

Docefrez may cause serious side effects. See "Drug Precautions" section.

The most common side effects of Docefrez include:

• infections
• changes in your sense of taste
• decreased appetite
• changes in your fingernails or toenails
• swelling of your hands, face or feet
• feeling weak or tired
• joint and muscle pain
• nausea and vomiting
• diarrhea
• constipation
• mouth or lips sores
• hair loss
• decrease in red blood cells, neutrophils, and/or platelets
• redness of the eye, excess tearing
• hypersensitivity reactions such as flushing, rash with or without itching, chest tightness, back pain, feeling short of breath, drug fever, or chills
• skin reactions at the site of Docefrez administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin.
• tissue damage if Docefrez leaks out of the vein into the tissues

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Docefrez. For more information ask your doctor or pharmacist.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ketoconazole
• ritonavir
• rifampin
• rifabutin

This is not a complete list of Docefrez drug interactions. Ask your doctor or pharmacist for more information.

Docefrez may cause serious side effects such as: 

• Toxicity resulting in death. (See the Black Box Warning). The chance of death in people who receive Docefrez is higher if you:
  • have liver problems
  • receive high doses of Docefrez
  • have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum
• Changes in Blood counts. Your doctor should do routine blood tests during treatment with Docefrez. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your doctor may not treat you with Docefrez until you have enough white blood cells. People with low white blood counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your doctor’s instructions for how often to take your temperature while taking Docefrez. Call your doctor right away if you have a fever.
• Serious Allergic reactions. Your doctor will typically monitor you for hypersensitivity reactions, especially during the first and second infusions. Your doctor will typically have you take oral corticosteroids before your dose of Docefrez. Tell your doctor right away if you have any of these signs of a serious allergic reaction:
  • trouble breathing
  • sudden swelling of your face, lips, tongue, throat, or trouble swallowing
  • hives (raised bumps), rash, or redness all over your body
• Harm to your unborn baby. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Docefrez.
• Liver problems. Docefrez may affect your liver. Your doctor will monitor your liver enzymes. 
• Eye disorder. Tell your doctor immediately if you notice any vision changes. 
• Acute Myeloid Leukemia (AML), a type of blood cancer, can happen in people who take Docefrez along with certain other medicines. Tell your doctor about all the medicines you take.
• Fluid retention. Patients typically experience fluid retention in the lower extremities. Tell if your doctor right away if you notice fluid retention. your doctor will typically have you take oral corticosteroids before your dose of Docefrez to prevent or reduce the severity of fluid retention. You must take the corticosteroid exactly as your doctor tells you. Tell your doctor or nurse before your Docefrez treatment if you forget to take corticosteroid dose or do not take it as your doctor tells you.
• Skin reactions including redness and swelling of your arms and legs with peeling of your skin may occur.
• Neurologic symptoms including numbness, tingling, or burning in your hands and feet can happen with this medication.

Docefrez Injection contains alcohol. The alcohol content in Docefrez Injection may impair your ability to drive or use machinery right after receiving Docefrez Injection. Consider whether you should drive, operate machinery or do other dangerous activities right after you receive Docefrez Injection treatment.

Do not receive Docefrez if you:

• have had a severe allergic reaction to:
  • docetaxel, the active ingredient in Docefrez, or
  • any other medicines that contain polysorbate 80.  Ask your doctor or pharmacist if you are not sure.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Docefrez there are no specific foods that you must exclude from your diet when receiving Docefrez.

Before you receive Docefrez, tell your doctor if you:

• are allergic to Docefrez
• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant
• breastfeeding or are planning to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Docefrez may affect the way other medicines work, and other medicines may affect the way Docefrez works.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Docefrez can cause harm to your unborn baby. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Docefrez.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Docefrez is excreted in human breast milk or if it will harm your nursing baby. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from Docefrez, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

• Docefrez will be given to you as an intravenous (IV) injection into your vein, usually over 1 hour.
• Docefrez is usually given every 3 weeks.
• Your doctor will decide how long you will receive treatment with Docefrez.
• Your doctor will check your blood cell counts and other blood tests during your treatment with Docefrez to check for side effects.
• Your doctor may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while taking Docefrez.

Your doctor will determine the dose and schedule of your Docefrez treatments depending on your condition and your response to the medicine. Your height and weight are used to calculate the dose as well.

Breast Cancer

• For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose range of Docefrez is 60 mg/m2 to 100 mg/m2 administered intravenously (through the vein) over 1 hour every 3 weeks.

Non-Small Cell Lung Cancer

• For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m2 administered intravenously (through the vein) over 1 hour every 3 weeks. 

• For chemotherapy-naïve patients: The recommended dose of Docefrez when given with cisplatin is Docefrez 75 mg/m2 administered intravenously (through the vein) over 1 hour immediately followed by cisplatin 75 mg/m2 over 30–60 minutes every 3 weeks.

Prostate Cancer

• For hormone-refractory metastatic prostate cancer, the recommended dose of Docefrez is 75 mg/m2 every 3 weeks as a 1 hour intravenous infusion (through the vein). Prednisone 5 mg orally twice daily is administered continuously.

Premedication Regimen

All patients should be premedicated with oral corticosteroids such as dexamethasone 16 mg per day (e.g., 8 mg BID) for 3 days starting 1 day prior to Docefrez administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.

For hormone-refractory metastatic prostate cancer, given the concurrent use of prednisone, the recommended premedication regimen is oral dexamethasone 8 mg, at 12 hours, 3 hours and 1 hour before the Docefrez infusion.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep all scheduled medical appointments. Your doctor will need to periodically monitor your progress and check for side effects. Be sure to keep appointments for laboratory and/or medical tests (e.g., blood cell counts and liver function tests) 
• Monitor your body temperature regularly and immediately tell your doctor if you develop a fever.
• Tell your doctor right away if you develop signs of allergy (hypersensitivity).
• Watch for signs of fluid retention such as swelling of legs and ankles, weight gain, and difficulty breathing.

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, AND FLUID RETENTION 

• Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m2 
• Should not be given if bilirubin > ULN, or if AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle 
• Should not be given if neutrophil counts are <1,500 cells/mm3. Obtain frequent blood counts to monitor for neutropenia 
• Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of DOCEFREZ and administration of appropriate therapy 
• Contraindicated if history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80 
• Severe fluid retention may occur despite dexamethasone