Nov-Onxol

Generic Name: paclitaxel (Intravenous route)

pak-li-TAX-el

Intravenous route(Solution)

Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in clinical trials. Fatal reactions have occurred in patients despite premedication and all patients should be pretreated with corticosteroids, diphenhydramine, and H(2) antagonists. Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm(3) and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1000 cells/mm(3). Monitor peripheral blood cell counts frequently .

Commonly used brand name(s)

In the U.S.

• Nov-Onxol


• Onxol


• Paclitaxel Novaplus


• Taxol

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Uses For Nov-Onxol

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 commonly found in patients with acquired immunodeficiency syndrome (AIDS).

Paclitaxel belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with paclitaxel, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, paclitaxel is used in certain patients with the following medical conditions:

• Cancer of the bladder.


• Cancer of the cervix.


• Cancer of the endometrium.


• Cancer of the esophagus.


• Cancer of the fallopian tube or lining of the abdomen (spreading from the ovary).


• Cancers of the head and neck.


• Cancer of the prostate.


• Cancer of the stomach


• Cancer of the testes.


• Cancer of unknown primary site.


• Small cell lung cancer (a certain type found in the tissues of the lungs).

Before Using Nov-Onxol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of paclitaxel injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paclitaxel injection in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., heart disease, bone marrow problems, and nerve problems), which may require caution in patients receiving paclitaxel injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Aprepitant


• Bacillus of Calmette and Guerin Vaccine, Live


• Bexarotene


• Cisplatin


• Deferasirox


• Doxorubicin Hydrochloride


• Ethinyl Estradiol


• Fosaprepitant


• Infliximab


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Pazopanib


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• St John's Wort


• Testosterone


• Tretinoin


• Typhoid Vaccine


• Valspodar


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dalfopristin


• Doxorubicin Hydrochloride Liposome


• Epirubicin


• Fosphenytoin


• Lapatinib


• Phenytoin


• Quinupristin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, 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 of hands, arms, legs, or feet)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight an infection.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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

Proper Use of paclitaxel

This section provides information on the proper use of a number of products that contain paclitaxel. It may not be specific to Nov-Onxol. Please read with care.

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.

Precautions While Using Nov-Onxol

It is very important that your doctor check your progress at regular visits to make sure 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 keep from getting pregnant. 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 with breathing; chest or throat tightness; 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 the vaccine is meant to prevent. In addition, you should not be around other persons living 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, increasing 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 the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical 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 you are 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 the 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.

Nov-Onxol Side Effects

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.

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More Nov-Onxol resources

• Nov-Onxol Use in Pregnancy & Breastfeeding
• Nov-Onxol Drug Interactions
• Nov-Onxol Support Group
• 2 Reviews for Nov-Onxol - Add your own review/rating

Compare Nov-Onxol with other medications

• Breast Cancer
• Breast Cancer, Adjuvant
• Breast Cancer, Metastatic
• Kaposi's Sarcoma
• Non-Small Cell Lung Cancer
• Ovarian Cancer
• Wilms' Tumor