Patient Medication Information: uses, side effects, how to take - Cyclophosphamide for Injection (DR Reddy's Laboratories)
Serious Warnings and Precautions
- cyclophosphamide is a potent cancer medicine, administered only by trained healthcare professionals
- you will have regular blood, liver, and kidney tests while receiving this medicine.
even a single dose may:
- harm your heart
- damage your lung
cyclophosphamide may:
- increase your risk of getting other cancers.
- lead to serious heart rhythm problems (QT prolongation and arrhythmia)
- damage your liver
severely lower your blood cell counts. This can lower your body’s ability to fight infections. This is called myelosuppression. While receiving this medicine:
- check your temperature often, especially if you feel unwell
- call your healthcare professional right away if you get a fever or feel signs of an infection (like chills, sore throat, or feeling very tired)
- harm your bladder and kidneys. If your urine (pee) turns pink or red, tell your healthcare professional right away. To prevent bladder problems, drink lots of water or other liquids
- cause life-threatening allergic reactions
- interact with certain medications called muscle relaxants
- certain type of vaccines (live vaccines) may cause infection in people receiving cyclophosphamide
- Cyclophosphamide for Injection contains alcohol. Talk to your healthcare professional before receiving this medicine
For more information on the serious side effects of cyclophosphamide, see the Serious side effects and what to do about them table, below.
What is Cyclophosphamide for Injection used for:
Cyclophosphamide for Injection is used alone or with other medications to treat the following type of cancer:
- lymphomas
- multiple myeloma
- leukemias
- mycosis fungoides
- neuroblastoma
- breast cancer
- retinoblastoma
- lung cancer
How does Cyclophosphamide for Injection work?
Cyclophosphamide is a cancer-fighting medicine. It belongs to a group of medicines called antineoplastics, and more specifically, to a class known as alkylating agents.
- it works by damaging the DNA of cancer cells, which slows or stops their growth and helps prevent the cancer from spreading
- because it also affects some healthy cells, it can cause side effects like hair loss, nausea, or low blood cell counts
What are the ingredients in Cyclophosphamide for Injection?
Medicinal ingredient: Cyclophosphamide
Nonmedicinal ingredients: ethanol anhydrous.
Cyclophosphamide for Injection comes in the following dosage forms:
Cyclophosphamide for Injection is available as a sterile solution in single-use vials with the following strengths:
- 500 mg / mL
- 1 g in 2 mL
- 2 g in 4 mL
Do not receive Cyclophosphamide for Injection if:
- you are allergic to this medicine, its ingredients, or anything used to make or store it.
- you have trouble passing urine (urinary blockage) or bladder infection
- you have very low blood cell counts (severe bone marrow suppression)
- you have serious kidney or liver problems
- you have a serious infection, especially chickenpox or shingles (varicella zoster).
- your immune system is severely weakened
- you are under 18 years old
- you are pregnant
- you are breastfeeding
- you are of Asian descent and have a specific genetic condition called ALDH2 mutation
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Cyclophosphamide for Injection. Talk about any health conditions or problems you may have, including if you:
have any of the following conditions:
- a heart condition called QT prolongation or a family history of it.
- electrolyte imbalances (problems with minerals like sodium in your blood).
- cancer that has spread to the brain or bone marrow
- low blood cell levels (low white blood cells, platelets, or red blood cells)
- liver or kidney problems
- trouble urinating or a bladder infection
- an active infection
- high serum creatinine levels (a waste product made by your muscles and remove through urine)
- have had surgery in the last 10 days or have upcoming surgery (including dental surgery), as cyclophosphamide can slow wound healing
- have received in the past a common cancer treatment known as radiation therapy
- are scheduled to receive a vaccine
you are caring for a child under 18 years old (cyclophosphamide is not recommended for children under 18)
Other warnings you should know about:
Pregnancy, Breastfeeding, and Fertility
If you are a woman:
Pregnancy: This medicine can harm an unborn baby
- do not receive cyclophosphamide if you are pregnant or planning to become pregnant
- if you become pregnant while taking cyclophosphamide tell your healthcare professional right away, to discuss the best options for you and your baby
- use effective birth control during treatment and for at least 12 months after the last dose
- talk to your healthcare professional about safe birth control options
Breastfeeding:
- do not breastfeed while receiving cyclophosphamide
- the medicine can pass into breast milk and harm your baby
If you are a man:
- if you are planning to father a child, talk to your healthcare professional before starting treatment
- if your partner is pregnant or may become pregnant, use effective birth control during treatment and for at least 6 months after your last dose
For both men and women:
Fertility:
- cyclophosphamide may affect your ability to have children in the future.
- if you are planning to have children later on, talk to your healthcare professional before starting treatment
Driving and using machines after your treatment:
- this medicine may make you feel dizzy, nauseous, less alert, or affect your balance and vision
- for 1 to 2 hours after your treatment, do not drive, use heavy machines, or do anything that needs your full attention
avoid alcohol while taking this medicine. It can make side effects like nausea
- and vomiting worse and may reduce how well the medicine works
- Alcohol in this medication
- this medication (Cyclophosphamide for Injection) contains alcohol, which can affect your brain and nervous system, especially right after treatment.
- if you need to avoid alcohol for medical or other reasons, talk to your healthcare professional before using this medicine
- Blood tests and monitoring: While you are taking cyclophosphamide, your healthcare team will do regular tests to make sure your body is handling the medicine safely. These may include:
- blood tests – to check your white blood cells, platelets, and red blood cells
- urine tests – to look for signs of bladder irritation or damage
- liver tests – to monitor how well your liver is working
- electrolyte tests – to check levels of essentials minerals like sodium and potassium
- lung tests – because this medicine can affect your lungs
- heart tests – to check your heart rhythm and function
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Cyclophosphamide for Injection:
- alcohol – can increase side effects like nausea and vomiting
- antibiotics – such as ciprofloxacin, metronidazole, rifampin, chloramphenicol, and sulfonamides
- blood thinners – like warfarin (Coumadin)
- antidepressants medicines – such as St. John’s wort and bupropion
- antifungal medications – like fluconazole and itraconazole
- stomach acid reducers – like cimetidine
- corticosteroids medicines – such as prednisone
- medications for alcohol use disorders – like disulfiram
- rheumatoid arthritis medicines – including etanercept and indomethacin.
- cholesterol medications – such as lovastatin
- gout medicines – like allopurinol
- seizure medications – such as phenytoin, carbamazepine, and phenobarbital
- blood pressure medicines – like ACE inhibitors and water pills (thiazide diuretics, e.g., hydrochlorothiazide)
- heart medicines – including amiodarone, digoxin, prasugrel, and verapamil.
- antinausea medications – like aprepitant and ondansetron
- medications that boost bone marrow – such as G-CSF and GM-CSF.
- other cancer treatments – including busulfan and tamoxifen
- medicines that affect the immune system – like cyclosporine, azathioprine, and methotrexate
- sedatives – medicines to help you feel calm, relaxed, or sleepy like chloral hydrate and benzodiazepines
- diabetes medicines – like sulfonylureas
- HIV medicines – such as protease inhibitors and zidovudine.
- vaccines – especially live vaccines (these can cause infection in people with weakened immune systems)
grapefruit:
- do not eat grapefruit or drink grapefruit juice while taking this medication.
- grapefruit contains a compound that can interfere with how cyclophosphamide works
- this may make the medicine less effective in treating your condition
- radiation – use to treat cancer: If you have had radiation to your chest or heart, let your healthcare professional know
How to receive Cyclophosphamide for Injection:
- your healthcare professional will give you cyclophosphamide through a vein (by IV)
- your healthcare professional may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well
Usual dose:
Your healthcare professional will:
- choose the right dose of Cyclophosphamide for Injection for you
- decide how often you should receive it
Overdose:
If you think you, or a person you are caring for, have taken too much Cyclophosphamide for Injection, contact a health care professional, hospital emergency department or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you miss a scheduled treatment, talk to your healthcare team as soon as possible to find out what to do.
What are possible side effects from using Cyclophosphamide for Injection
These are not all the possible side effects you may have when taking Cyclophosphamide for Injection. If you experience any side effects not listed here, tell your healthcare professional.
Cyclophosphamide for Injection may cause side effects. Tell your healthcare professional if any of these symptoms are severe or do not go away:
- nausea, vomiting, diarrhea, weight loss, or stomach pain
- loss of appetite or weight
- fatigue (tiredness)
- hair loss (in most cases, grow back after treatment, but the texture or color may change).
- sores on the mouth or tongue
- changes in skin color
- changes in color or growth of finger or toe nails
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
Myelosuppression (severely low blood cell counts)
| √ | ||
| Central Nervous System problems (problems that affect how your brain and spinal cord work): dizziness, confusion, convulsions, headache) | √ | ||
| Acute pancreatitis (inflammation of the pancreas, an organ that lies in the back of the mid-abdomen): sudden and severe pain in the upper belly that may spread to the back, fever, swollen or tender abdomen | √ | ||
| Rhabdomyolysis (muscle breaks down): severe muscle pain or weakness, dark-colored pee | √ | ||
| Liver problems: yellowish skin or eyes, unusually dark pee or pain on the right side of your belly | √ | ||
| Lung problems: new or worsening cough, burning sensation in the chest, shortness of breath, chest discomfort, trouble breathing during usual daily activities | √ | ||
Kidney and Urinary problems (Irritation of the bladder wall): pink or red colored urine (pee), blood in your pee; feel the need to pee urgently, have pain in your belly / lower belly area or pain when peeing | √ | ||
| Phlebitis (inflammation of vein): pain, hardening, and swelling of a vein in your arms or legs | √ | ||
| UNCOMMON | |||
| Heart problems: chest pain, fainting spells (passing out) or swelling in your legs, ankles and belly, new or worsening shortness of breath, a cough that does not go away, pounding or irregular heartbeat (palpitations), sudden weight gain (more than 5 pounds in 24 hours) | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness. | √ | ||
| Peripheral neuropathy: prickling, tingling, or numbness in the arms or legs | √ | ||
| Steven-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) (Serious skin reactions): any combination of itchy skin rash, redness, blistering and peeling of the skin and / or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands, joint pain, yellowing of the skin or eyes, dark-coloured pee | √ | ||
| Tumor lysis syndrome (occur when cancer cells break down rapidly, usually after starting cancer treatment): peeing less than usual, confusion, muscle twitching, seizures | √ | ||
| Anaphylaxis (serious allergic reactions): swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; or skin rash. | √ | ||
| Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) (a condition where the body makes too much antidiuretic hormone (ADH)—a hormone that helps control water balance): concentrated and dark urine (pee), muscle cramps, confusion, seizures | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
- Store vials in a refrigerator at 2°C to 8°C.
Do not use the medicine if:
- the liquid looks cloudy
- you see particles in it
- the color has changed
- the vial is leaking
If you want more information about Cyclophosphamide for Injection:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.drreddys.com, or by calling 1-855-845-1739.