Patient Medication Information: uses, side effects, how to take - Oritiniv
Serious warnings and precautions box
- Serious allergic reactions, including anaphylaxis, have been reported with the use of oritavancin.
What ORITINIV is used for:
- ORITINIV is used in adults to treat acute bacterial skin and skin structure infections (ABSSSI), caused by certain types of bacteria. ABSSSI is a type of skin and skin-related tissues infection.
- ORITINIV works against certain types of Gram-positive bacteria only. It can only be used to treat infections caused by these types of Gram-positive bacteria.
Antibacterial drugs like ORITINIV treat only bacterial infections. They do not treat viral infections such as the common cold.
How ORITINIV works:
ORITINIV is an antibacterial drug that contains the active substance oritavancin. Oritavancin is a type of antibiotic (lipoglycopeptide antibiotic) that can kill or stop the growth of certain bacteria.
The ingredients in ORITINIV are:
- ORITINIV 400 mg
Medicinal ingredients: Oritavancin (as oritavancin phosphate)
Non-medicinal ingredients: mannitol and phosphoric acid
- ORITINIV 1200 mg
Medicinal ingredients: Oritavancin (as oritavancin phosphate)
Non-medicinal ingredients: hydroxypropyl-β-cyclodextrin (HPβCD), mannitol and phosphoric acid or sodium hydroxide
ORITINIV comes in the following dosage forms:
Powder for solution; 400 mg/vial and 1200 mg/vial
Do not use ORITINIV if:
- you are allergic to oritavancin or any of the other ingredients in this drug (see The ingredients in ORITINIV are).
- you will be given intravenous unfractionated heparin sodium (blood thinner) within 5 days (120 hours) of receiving ORITINIV. Oritavancin interferes with certain laboratory anticoagulation tests used to monitor patients given intravenous unfractionated heparin sodium.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ORITINIV. Talk about any health conditions or problems you may have, including if you:
- have ever had an allergic reaction to glycopeptide antibiotics, such as vancomycin, teicoplanin* and ramoplanin*.
- have ever had an Infusion-related reactions (flushing of the upper body, hives, itching and/or rashes, chest pain, back pain, chills, and tremor) with the use of glycopeptide antibiotics.
- have or are suspected to have a bone infection (osteomyelitis).
- have or are suspected to have Clostridioides difficile-associated diarrhea (CDAD), which is a serious intestinal infection. If you have diarrhea, tell your healthcare professional before starting ORITINIV.
are pregnant.
are breastfeeding.
*Not available in Canada
Other warnings you should know about:
Oritavancin has been shown to interfere with certain laboratory coagulation tests. The results of these tests are unreliable after you have been given ORITINV. Your healthcare professional will use another method to monitor you.
- Oritavancin interferes with the test used to monitor the anticoagulant effect of warfarin. The result of this test is unreliable for up to 12 hours after receiving ORITINIV. If you are given ORITINIV and warfarin, your healthcare professional will monitor you for bleeding.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions:
Serious drug interactions with ORITINIV include:
- Intravenous unfractionated heparin sodium (blood thinning medicine) should not be used within 5 days (120 hours) of being given ORITINIV. Oritavancin interferes with certain laboratory anticoagulation tests used to monitor patients given intravenous unfractionated heparin sodium.
The following may also interact with ORITINIV:
- Warfarin (used to treat and prevent blood clots)
How to take ORITINIV:
- ORITINIV will be given to you by a healthcare professional in a healthcare setting.
- Although you may feel better in early treatment, your healthcare professional will continue to treat you with ORITINIV until the infection clears up.
- Misuse or overuse of ORITINIV could lead to the growth of bacteria that will not be killed by ORITINIV (resistance). This means ORITINIV may not work for you in the future.
Usual dose:
ORITINIV 400 mg: is given as a single 1200 mg dose (equivalent to 3 vials) into a vein over 3 hours.
ORITINIV 1200 mg: is given as a single 1200 mg dose into a vein over 1 hour.
Overdose:
In the event of overdose, supportive measures should be taken. Oritavancin is not removed from blood by hemodialysis.
If you think you, or a person you are caring for, have been given too much ORITINIV, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844-POISON-X (1-844-746-7669) immediately, even if there are no signs or symptoms.
Possible side effects from using ORITINIV:
These are not all the possible side effects you may have when taking ORITINIV. If you experience any side effects not listed here, tell your healthcare professional.
COMMON
- Dizziness
- Headache
- Diarrhea
- Nausea
- Vomiting
- Constipation
- Indigestion
- Hives
- Itchiness
- Muscle pain
- Inflammation of the vein at the infusion site
- Infusion site reaction
- Infusion site extravasation (drug leakage from IV into surrounding tissue)
- Abdominal pain
- Fever
- Fatigue
- Chills
- Device occlusion (blockage of the Intravenous line)
- Infection
- Insomnia
- Sore throat
- Cough
- Alanine aminotransferase increased
- Aspartame aminotransferase increased
UNCOMMON
- High uric acid levels in the body (Hyperuricaemia)
- Wheezing
- Inflammation of small blood vessels (Leukocytoclastic vasculitis)
- Flushing
- Inflammation of the tissue around your tendons (Tenosynovitis)
- Redness at the Infusion site (erythema)
- Hardening of the soft tissue at the Infusion site (infusion site induration)
- Itchiness at the Infusion site
- Rash at the Infusion site
- Blood bilirubin increased
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | 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 | |||
| Abscess (Limb and Subcutaneous) (pus-filled swelling in the skin or soft tissue of a limb): pain, swelling, redness, fever | ✓ | ||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, shortness of breath, weakness | ✓ | ||
| Cellulitis (skin infection): pain, tenderness, swelling, redness of the skin | ✓ | ||
| Dyspnea (shortness of breath): difficulty breathing, feel out of breath, chest tightness | ✓ | ||
| Hypertension (high blood pressure): dizziness or fainting, chest pain or pressure, racing pulse or heart palpitations | ✓ | ||
| Peripheral edema (swelling of the legs or hands caused by fluid retention): swollen or puffy legs or hands, feeling heavy, achy or stiff | ✓ | ||
| Tachycardia (abnormally fast heartbeat): dizziness, light headedness, shortness of breath, racing heart | ✓ | ||
| UNCOMMON | |||
| Angioedema (swelling of tissue under the skin): difficulty breathing; swollen face, hands and feet, genitals tongue, throat; Swelling of the digestive tract causing diarrhea, nausea or vomiting | ✓ | ||
| Bronchospasm (when there is a sudden narrowing of the airway): difficulty breathing with wheezing or coughing | ✓ | ||
| Eosinophilia (increased numbers of certain white blood cells): abdominal pain, rash, weight loss, wheezing. | ✓ | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blister or crust in the center; possibly | ✓ | ||
| swollen lips, mild itching or burning | |||
| Hypersensitivity (allergic reaction): fever, skin rash, hives, itching, swelling, shortness of breath, wheezing, runny nose, itchy, watery eyes | ✓ | ||
| Hypoglycemia (low blood sugar): thirst, frequent urination, hunger, nausea and dizziness, fast heartbeat, tingling trembling, nervousness, sweating, low energy | ✓ | ||
| Osteomyelitis (Infection of bone): swelling, pain in a specific bone with overlying redness, fever, and weakness | ✓ | ||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | ✓ | ||
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:
Your healthcare professional will store ORITINIV for you.
If you want more information about ORITINIV:
- 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 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.xediton.com, or by calling 1-800-XEDITON (933-4866).
Date of Authorization: SEP 12, 2025