Paclitaxel Novaplus (Intravenous)

Paclitaxel injection is used to treat advanced cancers of the ovaries, breast, non-small cell lung cancer, and Kaposi sarcoma. Kaposi sarcoma is a type of cancer affecting the skin and mucous membranes, often seen in patients with acquired immunodeficiency syndrome (AIDS).

Paclitaxel is part of a group of medicines called antineoplastics. It works by interfering with the growth of cancer cells, which are ultimately destroyed. However, it may also affect the growth of normal body cells, leading to other unwanted effects. Some of these effects can be serious and should be reported to your doctor. Other effects might not be serious but could still be concerning. Additionally, some effects may not appear until months or years after using the medicine.

Before starting treatment with paclitaxel, you and your doctor should discuss the benefits this medicine may provide as well as the risks associated with its use.

This medicine must be given only by or under the close supervision of your doctor.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a cough; dizziness; wheezing; trouble breathing; tightness in your chest or throat; swelling in your face or hands; fever; chills; rash; itching or hives; skin redness; or lightheadedness or faintness while you are receiving this medicine.

While you are being treated with paclitaxel, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Paclitaxel may lower your body's resistance, and the vaccine may not work as well, or you might get the infection that the vaccine is meant to prevent. In addition, you should not be around other people in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Paclitaxel can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in your urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause peripheral neuropathy. Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in your arms, hands, legs, or feet while using this medicine.

Cancer medicines can cause diarrhea, nausea, or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects if you still have nausea or vomiting after receiving the medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important things to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to determine how age affects the use of paclitaxel injection in children. Safety and effectiveness are not established for this group.

Geriatric

Studies so far have not found any specific problems in older adults that would limit the use of paclitaxel injection. However, older patients may be more likely to experience unwanted side effects (e.g., heart disease, bone marrow problems, and nerve problems), which may require caution when receiving paclitaxel injection.

Breast Feeding

There are no adequate studies in women to assess the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if there could be an interaction. If you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant and are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Abametapir
• Abiraterone Acetate
• Adenovirus Vaccine
• Amiodarone
• Aprepitant
• Atazanavir
• Bacillus of Calmette and Guerin Vaccine, Live
• Bexarotene
• Candesartan
• Carbamazepine
• Ceritinib
• Cholera Vaccine, Live
• Cisplatin
• Clopidogrel
• Conivaptan
• Crizotinib
• Dabrafenib
• Daridorexant
• Dengue Tetravalent Vaccine, Live
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Ethinyl Estradiol
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Idarubicin
• Infliximab
• Influenza Virus Vaccine, Live
• Itraconazole
• Ketoconazole
• Leflunomide
• Mavacamten
• Mitapivat
• Netupitant
• Nilotinib
• Omaveloxolone
• Oxcarbazepine
• Pazopanib
• Phenobarbital
• Phenytoin
• Pirtobrutinib
• Pixantrone
• Poliovirus Vaccine, Live
• Selpercatinib
• Smallpox Vaccine
• St John's Wort
• Taurursodiol
• Teriflunomide
• Testosterone
• Tretinoin
• Typhoid Vaccine, Live
• Valspodar
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Dalfopristin
• Lapatinib
• Quinupristin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtimes or with specific foods due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how this medicine works for you. Make sure to inform your doctor if you have any other medical issues, especially:

• Bradycardia (slow heart rate) or
• Heart rhythm problems or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Peripheral neuropathy (pain, numbness, or tingling in hands, arms, legs, or feet)—Use with caution. This may worsen these conditions.

• Infection—May reduce your body's ability to fight infections.

• Liver disease—Use with caution. Effects may be increased due to slower elimination of the medicine from the body.

• Neutropenia, severe (very low white blood cells)—Should not be used in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical attention.

Check with your doctor or nurse right away if you notice any of the following side effects:

More common

• Black or tarry stools
• Blurred vision
• Burning, numbness, tingling, or painful sensations
• Confusion
• Cough or hoarseness with fever or chills
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Feeling of warmth
• Fever or chills
• Lower back or side pain
• Painful or difficult urination
• Pale skin
• Redness of the face, neck, arms, and sometimes, upper chest
• Shortness of breath
• Skin rash or itching
• Sore throat
• Sweating
• Troubled breathing with exertion
• Ulcers, sores, or white spots in the mouth
• Unsteadiness or awkwardness
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Weakness in the arms, hands, legs, or feet

Less common

• Blood in the urine or stools
• Difficult or labored breathing
• Pinpoint red spots on the skin
• Shortness of breath (severe)
• Slow heartbeat
• Tightness in the chest
• Wheezing

Incidence not known

• Anxiety
• Blue lips, fingernails, or skin
• Difficult or troubled breathing
• Fainting
• Fast heartbeat
• Irregular, fast or slow, or shallow breathing
• Sudden shortness of breath

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Cracked lips
• Diarrhea
• Difficulty with swallowing
• Hair loss
• Nausea or vomiting
• Numbness, burning, or tingling in the hands or feet
• Pain in the joints or muscles, especially in the arms or legs
• Thinning of the hair

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Nov-Onxol
• Onxol
• Paclitaxel Novaplus
• Taxol

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Medicines used to treat cancer are very strong and can have many unwanted effects. Before receiving this medicine, you and your doctor should talk about the good this medicine will do as well as the risks of using it..

A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine is usually given every 3 weeks and is used together with other cancer medicines, such as cisplatin or doxorubicin.

You may also receive other medicines to help prevent allergic reactions and nausea or vomiting from paclitaxel.

• How long does chemo take? Sessions and recovery time?
• How soon can you start chemo after port placement?
• How soon will my hair grow back after chemotherapy?
• How do you manage neuropathy from chemo?
• Why give Taxol (Paxel) before carboplatin?
• Will I lose my hair during chemotherapy treatment?
• What is chemo brain and how long does it last?
• Radiation vs. Chemo: Which cancer treatment is right for you?
• What is Paxel called in the USA?

View more FAQ