Patient Medication Information: uses, side effects, how to take - Caspofungin Acetate for Injection (Sterimax)
ABOUT THIS MEDICATION
What the medication is used for:
Your doctor has prescribed Caspofungin Acetate for Injection to treat one of several types of fungal infections described below.
A serious fungal infection called invasive candidiasis. The
infection is caused by fungal (yeast) cells called Candida. These yeast cells are normally found in the digestive tract, and do not cause an infection unless they enter the bloodstream (in which case the infection is referred to as candidemia) or other tissues or organs, such as the lining of the abdomen (peritonitis), the kidneys, the liver, bones, muscles, joints, spleen, or eyes. Persons at high risk for invasive candidiasis include surgical patients and those whose immune systems are deficient.
Fungal infections of the mouth, back of the throat, and the food
tube connecting the mouth to the stomach. These infections are called oropharyngeal candidiasis (mouth and back of the throat) or esophageal (food tube) candidiasis. The infection is also caused by Candida. Healthy individuals usually have Candida in their mouth and throat without any ill effects. An infection occurs when the body’s resistance to disease is lowered.
A serious fungal infection called invasive aspergillosis.
Invasive aspergillosis is a serious infection of the nose, nasal sinuses, and lungs. This infection may spread to other parts of the body. This kind of infection is caused by a number of common fungi found in the environment called Aspergillus. Most Aspergillus fungal infections begin in the respiratory system (in the nose, sinuses, or lungs) because the spores of the fungus are found in the air we breathe every day. In most healthy individuals, the natural ability to fight disease destroys the spores and removes them from the body. Some medical conditions lower the body’s resistance to diseases. Also, certain medications prescribed for patients who are organ or bone marrow recipients lower the body’s resistance to diseases. These are the patients who are most likely to develop these infections.
Also, your doctor may suspect that you have a fungal infection in the following situation, and prescribe Caspofungin Acetate for Injection to treat it. Chemotherapy or other medical treatments or
conditions can lower the body’s resistance to disease by lowering counts of certain white blood cells. If you have persistent fever following chemotherapy or under other conditions as noted above, and your fever is not reduced by treatment with an antibiotic, you may have a fungal infection.
What it does:
Caspofungin Acetate for Injection is an antifungal drug that interferes with the production of a component (glucan polysaccharide) of the fungal cell wall that is necessary if the fungus is to continue living and growing. Fungal cells exposed to caspofungin acetate have incomplete or defective cell walls, making them fragile and unable to grow.
When it should not be used:
Who should not receive Caspofungin Acetate for Injection? Caspofungin Acetate for Injection should not be administered to you if you are allergic to any of its components (see “What the important nonmedicinal ingredients are”).
Use in children and adolescents:
Caspofungin Acetate for Injection has been approved for use in children > 12 months of age and adolescents for all the infection types described above. The dose used in pediatric patients may differ from the dose used in adult patients.
What the medicinal ingredient is:
Caspofungin acetate
What the nonmedicinal ingredients are:
Mannitol
Sucrose
Glacial acetic acid and/or Sodium hydroxide (as pH adjustors)
What dosage forms it comes in:
Powder for injection, 50 mg/vial and 70 mg/vial.
WARNINGS AND PRECAUTIONS
Serious warnings and precautions:
The use of Caspofungin Acetate for Injection and cyclosporine at the same time is not recommended.
Use in pregnancy and breast-feeding:
Caspofungin acetate has not been studied in pregnant women. Caspofungin Acetate for Injection should be used in pregnancy only if the doctor determines the potential benefit justifies the potential risk to the fetus.
Women receiving Caspofungin Acetate for Injection should not breast-feed.
Use in patients with Hepatic Insufficiency:
Some patients with liver problems may require a dosage
adjustment. Be sure to tell you doctor if you have had or now have liver problems.
BEFORE you use Caspofungin Acetate for Injection talk to your doctor or pharmacist if:
You have a history of allergic skin reactions (See
“Side Effects and What to Do About Them”)
- You are taking cyclosporine
In addition, you should always tell your doctor about all
other medications that you are taking or plan to take, including those obtained without a prescription. It is particularly important for your doctor to know if you are taking certain anti-HIV drugs (including efavirenz or nevirapine), the antiseizure (epilepsy) medications phenytoin and carbamazepine, the steroid dexamethasone, the antibiotic rifampin, and the immunosuppressant tacrolimus.
- You have liver problems
- You are pregnant or planning to become pregnant
- You are breast feeding or planning to breastfeed
You are allergic to any component of Caspofungin
Acetate for Injection
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Caspofungin Acetate for Injection
include
- Carbamazepine
- Cyclosporine
- Dexamethasone
- Efavirenz
- Nevirapine
- Phenytoin
- Rifampin
- Tacrolimus
PROPER USE OF THIS MEDICATION
Usual adult dose:
The treatment schedule and dosage will be set by your doctor, who will monitor your response and condition. Caspofungin Acetate for Injection should be administered once daily by slow intravenous infusion of approximately 1 hour.
A single 70 mg loading dose should be administered on Day 1, followed by 50 mg daily thereafter.
If you are treated for fungal infections of the mouth, back of the throat, and the food tube connecting the mouth to the stomach, 50 mg should be administered on Day 1 and daily thereafter.
Overdose
| If you are concerned that you may have been given too much | ||
| Caspofungin Acetate for Injection, contact a health care | ||
| practitioner, hospital emergency department or regional Poison | ||
| Control Centre immediately, even if there are no symptoms. |
Missed Dose:
If you are concerned that you may have missed a dose, contact your doctor immediately.
No dosage adjustment is necessary for the elderly.
No dosage adjustment is necessary for patients with reduced kidney function.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||
| Only if severe | In all cases | |||
| Common | Anemia (low red blood cells with symptoms such as weakness, tiredness, shortness of breath, pale skin) | ✓ | ||
| Liver problems with symptoms such as yellowing of the skin and eyes, abdominal pain, nausea, vomiting, pale stool. | ✓ | |||
| Swollen veins (phlebitis/ thrombophle- bitis) | ✓ | |||
| Uncommon | Serious allergic reaction and symptoms such as severe rash, itching, swelling of hands and feet, swelling of face and lips, trouble breathing | ✓ | ||
Any medicine may have unintended or undesirable effects, so- called side effects.
The most common medication-related undesirable effects in adults are fever and vein irritations at the infusion site (itching, redness, swelling, or clotting).
Other reported medication-related undesirable effects in adults include: headache, pain, bone pain, chills, rapid heartbeats, sweating, nausea, diarrhea, vomiting, rash, skin redness, itching, trouble breathing, swelling of the hands, ankles, or feet, impaired liver function, and alterations in some laboratory blood tests.
The most common medication-related undesirable effects in children and adolescents are fever, rash, and headache. Other reported medication-related undesirable effects in children and adolescents include: pain at the catheter site, chills, rapid heartbeat, flushing, itching, low blood pressure and alterations in some laboratory blood tests.
Life-threatening allergic reactions have been reported rarely during administration of caspofungin acetate and symptoms may include swelling of the face, lips and throat, difficulty in breathing, rash, itching, or sensation of warmth. If any combination of these symptoms occurs contact your doctor immediately.
Additionally, while the medicine has been on the market, the following have also been reported:
Severe, life-threatening skin conditions such as toxic
epidermal necrolysis and Stevens-Johnson syndrome. Contact your doctor immediately if you develop serious skin adverse reactions such as a severe rash, blisters, hives, large areas of peeling skin, mucous membrane sores or extensive sores in the mouth, throat and skin, often with accompanying fever, fatigue, flu-like symptoms and skin infection.
Other side effects may also occur rarely; and, as with any prescription medication, some side effects may be serious. Ask your doctor or pharmacist for more information. Tell your doctor or pharmacist promptly about these or any other unusual symptoms.
This is not a complete list of side effects. For any unexpected effects while taking Caspofungin Acetate for Injection contact your doctor or pharmacist.
HOW TO STORE IT
Store Caspofungin Acetate for Injection between 2ºC to 8ºC. Discard unused portion.
Reconstituted Caspofungin Acetate for Injection should be used immediately because it does not contain any preservatives to prevent bacterial contamination. Only a trained healthcare professional who has access to the complete directions provided with each vial can properly prepare this medication for use.
Keep out of reach and sight of children
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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
If you want more information about Caspofungin Acetate for Injection
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health- canada/services/drugs-health-products/drug- products/drug-product-database.html), or by calling 1-800-881-3550.
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4