Docefrez is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Docefrez is used to treat breast cancer, lung cancer, prostate cancer, stomach cancer, and head/neck cancer.

Docefrez may also be used for purposes not listed in this medication guide.

Docefrez can cause severe side effects including death, especially if you receive high doses, if you have liver disease, or if you have non-small cell lung cancer and you have been treated in the past with chemotherapy that contains platinum (cisplatin, carboplatin, oxaliplatin).

Docefrez can also cause a life-threatening allergic reaction. Get emergency medical help if you have hives, a red skin rash, difficulty breathing, if you feel like you might pass out, or if you have swelling of your face, lips, tongue, or throat.

Docefrez can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Docefrez may cause fluid retention or severe skin reactions. Call your doctor if you have swelling of your ankles or feet, rapid weight gain, or redness and peeling of the skin on your hands or feet.

Before taking this medicine

You should not receive Docefrez if you have a low white blood cell (WBC) count, or if you have ever had a severe allergic reaction to docetaxel or to any medicine that contains polysorbate 80.

Tell your doctor about your complete health history and all medications you have used. Docefrez can cause severe side effects including death, especially:

• if you receive high doses;

• if you have liver disease; or

• if you have non-small cell lung cancer and you have been treated in the past with chemotherapy that contains platinum (cisplatin, carboplatin, oxaliplatin).

To make sure Docefrez is safe for you, tell your doctor if you have ever had:

• liver disease or alcoholism;

• heart disease;

• fluid retention; or

• if you need to limit your alcohol intake.

Using Docefrez may increase your risk of developing other types of cancer, such as leukemia. Ask your doctor about your specific risk.

Do not use Docefrez if you are pregnant. It could harm the unborn baby. Use effective birth control to avoid pregnancy during your treatment with Docefrez. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether docetaxel passes into breast milk or if it could harm a nursing baby. You should not breast-feed while receiving Docefrez.

Docefrez is injected into a vein through an IV, usually once every 3 weeks. A healthcare provider will give you this injection. You may receive other cancer medicines at the same time.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

Docetaxel can be harmful if it gets on your skin during an IV infusion. If this happens, wash right away with soap and water.

Docefrez can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

You may be given steroid medication to help prevent serious side effects or allergic reaction. Keep using the steroid for as long as your doctor has prescribed.

You may need to have your vision checked if you have any vision problems while receiving Docefrez.

You should not receive Docefrez if you have a low white blood cell (WBC) count, or if you have ever had a severe allergic reaction to docetaxel or to any medicine that contains polysorbate 80.

Tell your doctor about your complete health history and all medications you have used. Docefrez can cause severe side effects including death, especially:

• if you receive high doses;

• if you have liver disease; or

• if you have non-small cell lung cancer and you have been treated in the past with chemotherapy that contains platinum (cisplatin, carboplatin, oxaliplatin).

To make sure Docefrez is safe for you, tell your doctor if you have ever had:

• liver disease or alcoholism;

• heart disease;

• fluid retention; or

• if you need to limit your alcohol intake.

Using Docefrez may increase your risk of developing other types of cancer, such as leukemia. Ask your doctor about your specific risk.

Do not use Docefrez if you are pregnant. It could harm the unborn baby. Use effective birth control to avoid pregnancy during your treatment with Docefrez. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether docetaxel passes into breast milk or if it could harm a nursing baby. You should not breast-feed while receiving Docefrez.

Call your doctor for instructions if you miss an appointment for your Docefrez injection, or if you miss a dose of your steroid medication.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

This medicine may impair your thinking or reactions for a short time after each injection. Be careful if you drive or do anything that requires you to be alert.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Docefrez contains alcohol and may cause a drunken feeling when the medicine is injected into your vein. Avoid drinking alcohol on the day of your Docefrez injection.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Docefrez: hives, red skin rash; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• sudden vision problems;

• redness, swelling, warmth, or skin changes where the injection was given;

• extreme weakness, severe vomiting or diarrhea;

• redness or peeling of the skin on your hands and feet;

• numbness, burning, or tingling in your hands or feet;

• signs of infection - fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• a feeling of being drunk - confusion, stumbling, extreme drowsiness;

• low blood cell counts - fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• low red blood cells - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• low platelets in your blood - easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• fluid retention - little or no urinating, swelling of your ankles or feet, rapid weight gain; or

• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Older adults may be more likely to have side effects from this medicine.

Common Docefrez side effects may include:

• feeling weak, tired, or short of breath;

• mouth sores, altered sense of taste;

• swelling;

• nausea, vomiting, loss of appetite;

• constipation, diarrhea;

• hair loss (may be permanent in some cases);

• muscle or joint pain;

• rash; or

• fingernail or toenail changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Docefrez contains alcohol. Using other drugs that can make you sleepy can worsen the feeling of being drunk. Ask your doctor before taking a sleeping pill, opioid pain medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with docetaxel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.