Docivyx (Docetaxel): Uses, Side Effects and Dosage

What is the most important information I should know about DOCIVYX ?

DOCIVYX may cause serious side effects, including death.

• The chance of death in people who receive DOCIVYX is higher if you:
• have liver problems
• receive high doses of DOCIVYX
• have non-small cell lung cancer and have been treated with chemotherapy medicines that contain platinum
• DOCIVYX can affect your blood cells. Your healthcare provider should do routine blood tests during treatment with DOCIVYX. This will include regular checks of your white blood cell counts. If your white blood cells are too low, your healthcare provider may not treat you with DOCIVYX until you have enough white blood cells. People with low white blood cell counts can develop life-threatening infections. The earliest sign of infection may be fever. Follow your healthcare provider's instructions for how often to take your temperature during treatment with DOCIVYX. Call your healthcare provider right away if you have a fever.
• Swelling (inflammation) of the small intestine and colon. This can happen at any time during treatment and could lead to death as early as the first day you get symptoms. Tell your healthcare provider right away if you develop new or worse symptoms of intestinal problems, including stomach (abdominal) pain or tenderness or diarrhea, with or without fever.
• Severe allergic reactions are medical emergencies that can happen in people who receive DOCIVYX and can lead to death. You may be at higher risk of developing a severe allergic reaction to DOCIVYX if you are allergic to paclitaxel. Your healthcare provider will monitor you closely for allergic reactions during your DOCIVYX infusion.

Tell your healthcare provider right away if you have any of these signs of a severe 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
• Your body may hold too much fluid (severe fluid retention) during treatment with DOCIVYX. This can be life threatening. To decrease the chance of this happening, you must take another medicine, a corticosteroid, before each DOCIVYX treatment. You must take the corticosteroid exactly as your healthcare provider tells you. Tell your healthcare provider or nurse before your DOCIVYX treatment if you forgot to take your corticosteroid dose or do not take it as your healthcare provider tells you. Tell your healthcare provider right away if you have swelling in your legs or feet, weight gain or shortness of breath.
• Risk of new cancers. An increase in new (second) cancers has happened in people treated with DOCIVYX together with certain other anticancer treatments. This includes certain blood cancers, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), non-Hodgkin's Lymphoma (NHL), and kidney cancer.

• Changes in blood counts due to leukemia and other blood disorders may occur years after treatment with DOCIVYX.

Your healthcare provider will check you for new cancers during and after your treatment with DOCIVYX.

• Severe skin problems.

Tell your healthcare provider right away if you have any of these signs of a severe skin reaction:

• redness and swelling of your arms and legs.
• blistering, peeling, or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms such as fever, chills, or muscle aches.
• red, scaly rash all over your body with blisters, small red or white bumps under the skin that contain pus (pustules), and fever.

What is DOCIVYX ?

DOCIVYX is a prescription anticancer medicine used to treat certain people with:

• breast cancer
• non-small cell lung cancer
• prostate cancer
• stomach cancer
• head and neck cancer

It is not known if DOCIVYX is effective in children.

Do not receive DOCIVYX if you:

• have a low white blood cell count.
• have had a severe allergic reaction to docetaxel, the active ingredient in DOCIVYX.

See "What is the most important information I should know about DOCIVYX ? " for the signs and symptoms of a severe allergic reaction.

See the end of this Patient Information for a complete list of the ingredients in DOCIVYX.

Before you receive DOCIVYX , tell your healthcare provider about all of your medical conditions, including if you:

• are allergic to any medicines, including paclitaxel. See " Do not receive DOCIVYX if you ".
• have liver problems
• have kidney problems

• are pregnant or plan to become pregnant. DOCIVYX can harm your unborn baby. You should not become pregnant during treatment with DOCIVYX. Tell your healthcare provider if you become pregnant or you think you may be pregnant during treatment with DOCIVYX.

Females who are able to become pregnant:

• Your healthcare provider will check to see if you are pregnant before you start treatment with

DOCIVYX.

• You should use effective birth control (contraception) during treatment with DOCIVYX and for 2 months after the last dose.

Males with female partners who are able to become pregnant should use effective birth control during treatment with DOCIVYX and for 4 months after the last dose.

Talk to your healthcare provider if you have questions about birth control options that are right for you.

• are breastfeeding or plan to breastfeed. It is not known if DOCIVYX passes into your breast milk. Do not breastfeed during treatment with DOCIVYX and for 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. DOCIVYX may affect the way other medicines work, and other medicines may affect the way DOCIVYX works.

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

How will I receive DOCIVYX ?

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

What are the possible side effects of DOCIVYX ?

DOCIVYX may cause serious side effects including death.

• See "What is the most important information I should know about DOCIVYX ?"
• Neurologic problems. Neurologic symptoms are common in people who receive DOCIVYX but can be severe. Tell your healthcare provider right away if you have numbness, tingling, or burning in your hands or feet (peripheral neuropathy) or weakness of your legs, feet, arms, or hands (motor weakness).
• Vision problems including blurred vision or loss of vision. Tell your healthcare provider right away if you have any vision changes.

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

• Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, or heart problems, and may lead to death. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with DOCIVYX. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with DOCIVYX, including:

○ nausea

○ vomiting

○ confusion

○ shortness of breath

○ irregular heartbeat

○ dark or cloudy urine

○ reduced amount of urine

○ unusual tiredness

○ muscle cramps

• You may experience side effects of this medicine that may impair your ability to drive, use tools, or operate machines. If this happens, do not drive or use any tools or machines before discussing with your healthcare provider.

The most common side effects of DOCIVYX include:

• infections
• low white blood cells (help fight infections), low red blood cells (anemia), and low platelets (help blood to clot)
• allergic reactions (See "What is the most important information I should know about DOCIVYX ?" )
• changes in your sense of taste
• shortness of breath
• constipation
• 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
• mouth or lip sores
• hair loss: in some people, permanent hair loss has been reported
• redness of the eye, excess tearing
• skin reactions at the site of Docetaxel Injection administration such as increased skin pigmentation, redness, tenderness, swelling, warmth or dryness of the skin
• tissue damage if Docetaxel Injection leaks out of the vein into the tissues

Tell your healthcare provider if you have a fast or irregular heartbeat, severe shortness of breath, dizziness or fainting during your infusion. If any of these events occurs after your infusion, get medical help right away.

DOCIVYX may affect fertility in males. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of DOCIVYX. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of DOCIVYX .

Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. You can ask your pharmacist or healthcare provider for information about DOCIVYX that is written for health professionals

What are the ingredients in DOCIVYX ?

Active ingredient: docetaxel

Inactive ingredients: sulfoxybutyl ether cyclodextrin (SBECD), polyethyleneglycol 300, polyvinyl pyrroldine K₁₂, and dehydrated alcohol in water for injection, with citric acid for pH adjustment.

Manufactured for:

Avyxa Pharma, LLC

New Jersey 07054, USA

Made in China

Rx Only

For more information, call 1-888-520-0954.