Patient Medication Information: uses, side effects, how to take - Xydalba
What is XYDALBA used for?
XYDALBA is used to treat adults and children (3 months of age and older) with infections of the skin or in the layers of flesh below the skin.
Antibacterial drugs like XYDALBA treat only bacterial infections. They do not treat viral infections such as the common cold.
How does XYDALBA work?
XYDALBA is an antibiotic. It belongs to a group of antibiotics called glycopeptide antibiotics. XYDALBA works by killing certain bacteria that cause serious infections. It kills these bacteria by preventing them from making their cell walls.
What are the ingredients in XYDALBA?
Medicinal ingredient: dalbavancin (as dalbavancin hydrochloride)
Non-medicinal ingredients: mannitol, lactose monohydrate, hydrochloric acid and/or sodium hydroxide (for pH adjustment only)
XYDALBA comes in the following dosage form:
Each vial contains 500 mg dalbavancin (as dalbavancin hydrochloride) as a lyophilized powder for solution.
Do not use XYDALBA if:
- you are allergic to dalbavancin
- you are allergic to any of the other ingredients in XYDALBA or any part of the container
XYDALBA should not be given to patients less than 3 months of age. It is not known if XYDALBA is safe and effective in these patients.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take XYDALBA. Talk about any health conditions or problems you may have, including if you:
- have or have had kidney problems. Your doctor may reduce your dose of XYDALBA if your kidneys are not working properly.
- have liver problems.
- are suffering from diarrhea, or you have previously suffered from diarrhea when being treated with antibiotics.
- are allergic to other antibiotics called glycopeptide antibiotics like vancomycin or teicoplanin.
- are pregnant or planning to become pregnant.
- are breastfeeding.
Other warnings you should know about:
Other infections
Using antibiotics may sometimes allow a new and different infection to develop. If you think you might have a new infection, talk to your healthcare professional.
Pregnancy
XYDALBA is not recommended during pregnancy unless clearly necessary. This is because it is not known what effect it might have on an unborn baby. Before you are given this medicine, tell your healthcare professional if you are pregnant, think you may be pregnant or are planning to have a baby. You and your healthcare professional will decide if you will be given XYDALBA.
Breastfeeding
XYDALBA may pass into breast milk. Ask your healthcare professional for advice before breastfeeding your baby. You and your healthcare professional will decide if you will be given XYDALBA while breastfeeding.
Driving and using machines
XYDALBA may cause dizziness and this may affect your ability to drive and use machines. Before driving or using machines, wait until you are feeling well again.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take XYDALBA
- XYDALBA will be given to you by a healthcare professional.
- It will be infused directly into your vein.
- It will be infused over a period of 30 minutes.
- Follow all instructions given to you by your healthcare professional.
Usual dose:
Adults (18 years old and older): XYDALBA is given in a single dose of 1500 mg or in two doses one week apart: 1000 mg on Day 1 and 500 mg on Day 8. Your healthcare professional will decide whether you will receive one or two doses of XYDALBA.
Children (6 years old to under 18 years old): XYDALBA is given in a single dose. The amount of XYDALBA given is 18 mg for every kg of body weight. The maximum single dose is 1500 mg.
Children (3 months old to under 6 years old): XYDALBA is given in a single dose. The amount of XYDALBA given is 22.5 mg for every kg of body weight. The maximum single dose is 1500 mg.
If you have kidney problems, your healthcare professional may decide to reduce your dose. There is not enough information to recommend the use of XYDALBA for children with chronic kidney problems.
Overdose:
If you think you, or a person you are caring for, have taken too much XYDALBA, contact a healthcare professional, hospital emergency department, 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.
What are possible side effects from using XYDALBA?
These are not all the possible side effects you may feel when taking XYDALBA. If you experience any side effects not listed here, contact your healthcare professional.
Common side effects may include:
- Headache
- Nausea (feeling sick)
- Diarrhea
- Fever
- Cough
Other side effects may include:
- Insomnia (trouble sleeping)
- Dizziness
- Vomiting
- Constipation
- Swelling of the hands or feet
XYDALBA can cause abnormal blood test results. Your healthcare professional may perform blood tests and will interpret the results.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
| Anemia (decreased red blood cells): dizziness, fatigue, loss of energy, shortness of breath, weakness | ✓ | ||
| Cellulitis (skin infection): pain, tenderness, redness of the skin | ✓ | ||
| Difficulty breathing | ✓ | ||
| Liver problems: abdominal pain, dark urine, fatigue, loss of appetite, nausea, vomiting, yellowing of the skin or eyes (jaundice) | ✓ | ||
| Urinary tract infection: difficulty or increased need to urinate, pain or burning sensation when passing urine, fever, pain in the abdomen or mid-back, urine that appears cloudy | ✓ | ||
| UNCOMMON | |||
| Clostridium difficile colitis (bowel inflammation): abdominal pain or tenderness, fever, severe diarrhea (bloody or watery) | ✓ | ||
| Eosinophilia (increased numbers of certain white blood cells): abdominal pain, rash, weight loss, wheezing | ✓ | ||
| Bleeding in the digestive tract: abdominal pain, blood in stool, blood in vomit | ✓ | ||
| Neutropenia (decreased white blood cells): aches, bleeding gums, feeling tired, fever, flu-like symptoms, infections, sore mouth and gums, mouth ulcer, rash | ✓ | ||
| Oral candidiasis (yeast infection of the mouth): bad taste in the mouth, creamy white bumps on the tongue, cheeks, gums or throat that bleed when scraped, pain, trouble swallowing | ✓ | ||
| Phlebitis (swelling of a vein): pain, tenderness, redness or swelling of a body area | ✓ | ||
| Thrombocytopenia (decreased platelets in the blood): bleeding, bruising, fatigue, weakness | ✓ | ||
| Thrombocytosis (increased platelets in the blood): chest pain, dizziness, headache, red, warm or tingling hands and feet, weakness | ✓ | ||
| Yeast infection of vagina: itching, burning, pain, redness, swelling or irritation of the vagina or vulva, a thick, white vaginal discharge with a cottage cheese appearance | ✓ | ||
| RARE | |||
| Allergic reactions: difficulty breathing, difficulty swallowing, fever, hives, itchy skin, rash, swelling of your tongue or throat | ✓ | ||
| Bronchospasm (sudden tightening of the lung muscles): difficulty breathing | ✓ | ||
| Petechiae (spots on the skin): purple or red round spots on skin | ✓ | ||
| Spontaneous bruising | ✓ | ||
| Bleeding from an existing wound | ✓ | ||
| UNKNOWN | |||
| Hearing problems: change in hearing, dizziness, problems with balance, ringing in the ears, vertigo (spinning sensation) | ✓ | ||
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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at room temperature (15-30°C).
Keep out of reach and sight of children.
If you want more information about XYDALBA:
- 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); the manufacturer’s website (https://knighttx.com), by emailing medinfo@knighttx.com or by calling 1-844-483-5636.