Nov-Onxol (Intravenous)

Paclitaxel injection is used to treat advanced cancer of the ovaries, breast, non-small cell lung cancer, and Kaposi sarcoma. Kaposi sarcoma is a cancer of the skin and mucous membranes that is 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 eventually destroyed. Because it can also affect the growth of normal body cells, it may cause other unwanted effects. Some of these effects can be serious and should be reported to your doctor. Other effects may not be serious but could still be concerning. 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 of this medicine as well as the risks associated with it.

This medicine should only be given by or under the direct supervision of your doctor.

It is very important that your doctor checks your progress during regular visits to ensure that this medicine is working properly. Blood tests may be needed to look for side 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 may be pregnant while using this medicine, inform your doctor immediately.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and needs 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 feeling lightheaded or faint while receiving this medicine.

While you are being treated with paclitaxel, and after you stop treatment with it, do not get any immunizations (vaccines) without your doctor's approval. Paclitaxel may lower your body's resistance, which can affect how well the vaccine works, or you might get the infection that the vaccine is meant to prevent. Also, avoid being around others in your household who receive live virus vaccines, as they might pass the virus to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Stay away from them and do not spend a lot of time in the same room with them. If you have questions about this, talk to your doctor.

Paclitaxel can temporarily lower your white blood cell count, increasing your risk of getting an infection. It can also lower the number of platelets needed for proper blood clotting. If this happens, there are some precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If possible, avoid people with infections. Contact your doctor immediately if you think you have an infection or if you develop a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in your urine or stools; or tiny red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Consult 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 since.
• Be cautious when using sharp objects like a safety razor or fingernail or toenail cutters to avoid cutting yourself.
• Avoid contact sports or other activities where bruising or injury could happen.

This medicine may cause peripheral neuropathy. Contact your doctor right away if you experience burning, numbness, tingling, or pain in your arms, hands, legs, or feet while using this medicine.

Cancer medicines can cause diarrhea, nausea, or vomiting in many people, even after receiving medications to prevent these effects. Ask your doctor or nurse about other ways to manage these side effects if you continue to experience nausea or vomiting after receiving the medicine.

Do not take other medicines unless you have discussed them 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 consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

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

Pediatric

There have not been enough studies to determine how paclitaxel injection affects children. Safety and effectiveness in this age group have not been proven.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of paclitaxel injection. However, older patients may be more likely to experience side effects (such as heart disease, bone marrow problems, and nerve problems), which may require special care when using paclitaxel injection.

Breast Feeding

There are no sufficient studies in women to assess the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two medicines can be used together even if an interaction may occur. If you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been highlighted due to their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose 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 generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, 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 it may be the best option for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Dalfopristin
• Lapatinib
• Quinupristin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how you can use this medicine. Be 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. May worsen these conditions.

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

• Liver disease—Use with caution. Effects may be stronger due to slower removal 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 needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

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 occasionally, 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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 occur 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.

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