Paclitaxel for Injection by Biolyse Pharma Corporation

Brand Name

Paclitaxel for Injection by Biolyse Pharma Corporation

Common Name

paclitaxel

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Paclitaxel belongs to the group of cancer-fighting medications known as antineoplastics. Paclitaxel works by slowing or stopping the growth of cancer cells in your body. Paclitaxel is used alone or in combination with other cancer medications to treat cancers of the ovary, breast, or lung. 

Nab-paclitaxel is a slightly different form of the same medication. It is used alone or in combination with other cancer medications to treat breast cancer that has spread (metastasized), or in combination with other medications to treat cancer of the pancreas that has metastasized.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor.

How should I use this medication?

The recommended dose and dosing schedule of paclitaxel varies according to the specific type of cancer being treated, the response to treatment, and other medications or treatments being used. The dose given is also based on body size. Paclitaxel is usually injected into a vein (intravenously) by a qualified health care professional through a specially prepared site on your skin. It is often scheduled to be given in this manner over a 3-hour period once every 3 weeks.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. Very careful handling of this medication is required. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive paclitaxel, contact your doctor as soon as possible to reschedule your appointment.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Each mL of sterile nonpyrogenic solution contains 6 mg of paclitaxel from Taxus Canadensis, 527 mg of Cremophor® EL (purified polyethoxylated castor oil), and 49.7% (v/v) dehydrated alcohol, USP.

Who should NOT take this medication?

Do not use paclitaxel if you:

• are allergic to paclitaxel, polyethoxylated castor oil, or any ingredients of the medication
• have a very low level of neutrophils (a type of white blood cell) in the blood

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• changes in skin appearance
• diarrhea or loose, runny stools
• discolouration of the nail beds
• fatigue
• flushing
• dizziness when rising from a sitting or lying position
• numbness, burning, or tingling in the hands or feet
• pain in joints or muscles
• sores in the mouth and on the lips
• temporary loss of hair, eyebrows, eyelashes, and pubic hair about 2 to 3 weeks after treatment
• upset stomach (or nausea)
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision or other visual changes
• cough or hoarseness with fever or chills
• fever or chills
• fast or irregular heartbeat, or lightheadedness occurring during your treatment
• pain or redness at the site of the injection
• severe weakness or tiredness
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• shortness of breath or wheezing

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• seizures
• severe, persistent watery diarrhea (may or may not be bloody)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• symptoms of respiratory failure (e.g., rapidly worsening shortness of breath, bluish colour to lips or skin, irregular heartbeat, sleepiness, decreased level of consciousness)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: This medication may cause an allergic reaction (flushing of the face, severe back pain, chest tightness, shortness of breath) within the first few minutes of receiving paclitaxel. You will be asked to take some medication prior to treatment with paclitaxel to reduce your chances of experiencing a reaction.

Anemia: Paclitaxel may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Arrhythmia: People with heart rhythm problems may experience a worsening of these problems due to this medication. If you have a heart problem, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Blood clotting: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly as usual. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that do not stop bleeding.

Drowsiness/reduced alertness: This medication may cause fatigue and weakness which may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Eye problems: Paclitaxel may cause a rare eye problem called cystoid macular edema, which results in blurred vision due to swelling of the retina. If you notice blurred vision or any other vision changes, notify your doctor immediately.

Infection: As well as killing cancer cells, this medication can reduce the number of cells that fight infection in the body (white blood cells). Avoid contact with people who have a contagious infection and tell your doctor immediately if you begin to notice signs of an infection, such as fever or chills.

Liver function: Liver disease or reduced liver function may cause increased side effects with this medication. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor will test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Nerve pain: Paclitaxel may cause a mild burning, tingling, or numbing sensation of the fingers and toes. This side effect is rarely severe and usually goes away once you finish treatment.

Skin problems: Occasionally, paclitaxel causes irritation at the site where the needle enters the skin. This may cause redness, warmth, swelling, and pain at the injection site. When this is not managed immediately, it can cause infection and destruction of the skin and tissues underneath. If you experience any unexpected changes to your skin, talk to your doctor as soon as possible.

Pregnancy: There are no adequate studies of use of this medication by pregnant women, however paclitaxel may cause severe harm to a developing baby if it is used by the mother during pregnancy. This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if paclitaxel passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: People over the age of 65 may be at increased risk of side effects from this medication.

What other drugs could interact with this medication?

There may be an interaction between paclitaxel and any of the following:

• other cancer medications (e.g., cisplatin, cladribine, teniposide, etoposide, vincristine)
• abiraterone acetate
• aliskiren
• alpha-agonists (e.g., clonidine, methyldopa)
• alpha-blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
• amphotericin B
• angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• antiarrhythmic medications (e.g., amiodarone, dronedarone, quinidine)
• anti-psychotic medications (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• apomorphine
• aprepitant
• atorvastatin
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• barbiturates (e.g., phenobarbital, secobarbital)
• baricitinib
• BCG vaccine
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• bosentan
• brimonidine
• bromocriptine
• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
• carbamazepine
• clopidogrel
• cobicistat
• conivaptan
• corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, fluticasone, prednisone)
• deferasirox
• denosumab
• diazepam
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• duloxetine
• echinacea
• enzalutamide
• gemfibrozil
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• iron sucrose
• leflunomide
• levodopa
• lomitapide
• lumacaftor and ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mesalamine
• mifepristone
• montelukast
• morphine
• nabilone
• natalizumab
• nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• obinutuzumab
• ocrelizumab
• olsalazine
• pentoxifylline
• phenytoin
• phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
• pimecrolimus
• primidone

• protein kinase inhibitors (e.g., ceritinib, crizotinib, dabrafenib, idelalasib, imatinib, nilotinib, ribociclib)

• retinoic acid
• rifabutin
• rifampin
• St. John's wort
• sphingosine 1-phosphate receptor (S1P) receptor inhibitors (e.g., fingolimod, ponesimod, siponimod)
• sulfasalazine
• tacrolimus
• tofacitinib
• upadacitinib
• vaccines
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Paclitaxel-for-Injection-by-Biolyse-Pharma-Corporation