Taxotere

DRUG DESCRIPTION

Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5?-20-epoxy-l,2?,4,7?,10?,13?-hexahydroxytax-ll-en-9-one 4-acetate 2-benzoate, trihydrate. Docetaxel has the following structural formula:

TAXOTERE</b><br />
  (docetaxel) Injection Concentrate, Intravenous Infusion (IV) Structural Formula Illustration

Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO143H2O and a molecular weight of 861.9. It is highly lipophilic and practically insoluble in water.

One-vial TAXOTERE (Injection Concentrate)

TAXOTERE (docetaxel) Injection Concentrate is a sterile, non-pyrogenic, pale yellow to brownish-yellow solution at 20 mg/mL concentration.

Each mL contains 20 mg docetaxel (anhydrous) in 0.54 grams polysorbate 80 and 0.395 grams dehydrated alcohol solution.

TAXOTERE is available in single use vials containing 20 mg (1 mL) or 80 mg (4 mL) docetaxel (anhydrous).

TAXOTERE Injection Concentrate requires NO prior dilution with a diluent and is ready to add to the infusion solution.

What are the possible side effects of docetaxel (Taxotere)?

Some people receiving a docetaxel injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, warm, or itchy, or if you have chest tightness or trouble breathing during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • easy...

Read All Potential Side Effects and See Pictures of Taxotere

What are the precautions when taking docetaxel for injection (Taxotere)?

Before using ceftaroline, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

Ceftaroline may cause live bacterial vaccines (such as typhoid vaccine) to work less well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and...

Read All Potential Precautions of Taxotere


Taxotere Consumer (continued)

SIDE EFFECTS: Pain, redness, or swelling at the injection site may occur. Nausea or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ceftaroline, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

Ceftaroline may cause live bacterial vaccines (such as typhoid vaccine) to work less well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant before using this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Taxotere Patient Information Including Side Effects

Brand Names: Taxotere

Generic Name: docetaxel (Pronunciation: doe se TAX el)

  • What is docetaxel (Taxotere)?
  • What are the possible side effects of docetaxel (Taxotere)?
  • What is the most important information I should know about docetaxel (Taxotere)?
  • What should I discuss with my healthcare provider before using docetaxel (Taxotere)?
  • How is docetaxel used (Taxotere)?
  • What happens if I miss a dose (Taxotere)?
  • What happens if I overdose (Taxotere)?
  • What should I avoid while using docetaxel (Taxotere)?
  • What other drugs will affect docetaxel (Taxotere)?
  • Where can I get more information?

What is docetaxel (Taxotere)?

Docetaxel is a cancer medicine that slows the growth and spread of cancer cells in the body.

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

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

What are the possible side effects of docetaxel (Taxotere)?

Some people receiving a docetaxel injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, warm, or itchy, or if you have chest tightness or trouble breathing during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • easy bruising or bleeding, unusual weakness;
  • feeling like you might pass out;
  • fever, chills, body aches, flu symptoms;
  • severe diarrhea;
  • skin changes or bruising where the IV was placed;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • feeling short of breath, even with mild exertion;
  • swelling of your ankles or feet, weight gain;
  • a red, blistering, peeling skin rash; or
  • numbness, burning, pain, or tingly feeling.

Less serious side effects may include:

  • feeling weak or tired;
  • white patches or sores inside your mouth or on your lips;
  • mild nausea, vomiting, diarrhea, constipation, or loss of appetite;
  • watery eyes;
  • changes in menstrual periods;
  • temporary hair loss; or
  • fingernail or toenail changes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about docetaxel (Taxotere)?

Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Before being treated with docetaxel, tell your doctor if you have ever been treated with cisplatin (Platinol), or if you have liver disease, congestive heart failure, fluid retention, swelling problems, or if you have ever had an allergic reaction to docetaxel.

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

Some people receiving a docetaxel injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, warm, or itchy, or if you have chest tightness or trouble breathing during the injection.

Docetaxel can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection, especially fever.

There are many other drugs that can interact with docetaxel. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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