Patient Medication Information: uses, side effects, how to take - Anthim
What is ANTHIM used for?
- ANTHIM is a prescription medicine used along with antibiotic medicines to treat people with inhalational anthrax. ANTHIM can also be used to prevent anthrax disease after exposure to anthrax spores when there are no other treatment options.
- The effectiveness of ANTHIM has been studied only in animals with inhalational anthrax. There have been no studies in people who have inhalational anthrax.
The safety of ANTHIM was studied in healthy adults. There have been no studies of ANTHIM in children younger than 18 years.
- ANTHIM is not used in prevention or treatment of anthrax meningitis.
How does ANTHIM work?
ANTHIM contains the active substance obiltoxaximab. Obiltoxaximab is a monoclonal antibody, a specific type of protein that inactivates the toxins produced by Bacillus anthracis, the bacteria causing anthrax disease.
What are the ingredients in ANTHIM?
Medicinal ingredients: obiltoxaximab
Non-medicinal ingredients: hydrochloric acid, L-histidine, polysorbate 80, sodium hydroxide, sorbitol and water for injection.
Serious Warnings and Precautions
Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.
“HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY USE NEW DRUG FOR ADULT AND PEDIATRIC PATIENTS FOR TREATMENT OF INHALATIONAL ANTHRAX DUE TO BACILLUS ANTHRACIS IN COMBINATION WITH APPROPRIATE ANTIBACTERIAL DRUGS, AND FOR PROPHYLAXIS OF INHALATIONAL ANTHRAX WHEN ALTERNATIVE THERAPIES ARE NOT AVAILABLE OR ARE NOT APPROPRIATE, BASED ON LIMITED CLINICAL TESTING IN HUMANS.”
ANTHIM comes in the following dosage forms:
Vial containing solution of 600 mg of obiltoxaximab/6 mL (100 mg/mL)
Do not use ANTHIM if:
- if you are allergic to obiltoxaximab or any of the other ingredients of this medicine
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ANTHIM. Talk about any health conditions or problems you may have, including:
- if you have a hypersensitivity or if you have had an allergic reaction to obiltoxaximab or any of the other ingredients of this medicine. Your healthcare professional will monitor you during and after the administration of ANTHIM for signs of hypersensitivity
Other warnings you should know about:
Pregnancy and breast-feeding: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before this medicine is given to you. It is not known if ANTHIM can harm an unborn baby. It is not known if ANTHIM passes into your breast milk and what effect ANTHIM may have on the breast-fed child. You and your doctor should decide if you should breast-feed after receiving ANTHIM.
Driving and using machines: ANTHIM may cause side effects such as headache, dizziness, and fatigue. This may impair your ability to drive or operate machinery.
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 ANTHIM:
- You may be given antibiotics to help treat Anthrax Disease. ANTHIM and antibiotics do not interfere with each other.
How to take ANTHIM:
ANTHIM will be given to you by a doctor or a nurse. Your doctor or nurse will calculate the dose based on your/your child’s body weight.
Your doctor, nurse or pharmacist will prepare the medicine for infusion.
The ANTHIM solution will be given as an infusion (drip) over 1.5 hours into one of your veins, usually in your arm. You will be monitored while you are given ANTHIM and also for at least one hour after the infusion.
Before you are given ANTHIM, you will be given other medicines to prevent or reduce possible allergic reactions.
Usual dose:
The recommended dosage of ANTHIM in adult patients is a single dose of 16 mg/kg.
The recommended dose for pediatric patients is based on weight.
Overdose:
| There is no clinical experience with overdosage of ANTHIM. In case of overdosage, monitor patients for any signs or symptoms of adverse effects. |
Missed Dose:
Not applicable.
What are possible side effects from using ANTHIM?
These are not all the possible side effects you may feel when taking ANTHIM. If you experience any side effects not listed here, contact your healthcare professional.
Common side effects (may affect up to 1 in 10 people):
- Infusion site swelling
- Infusion site pain
- Arm or leg pain
Uncommon side effects (may affect up to 1 in 100 people):
- Dizziness postural
- Ear discomfort
- Visual sensitivity to light (photophobia)
- Sinus congestion
- Dry mouth
- Lip pain
- Fatigue
- Chest pain
- Tenderness
- Vessel puncture site pain
- Allergic reactions
- Decreased lymphocyte count
- Decreased neutrophil count
- Decreased white blood cell count
- Muscle spasms, muscle twitching, muscle aches
- Pain in the jaw
- Numbness
- Lack of energy (lethargy)
- Migraine with aura
- Restlessness
- Dry throat
- Nasal or Sinus congestions
- Itchy skin (dermatitis allergic)
- Flaky skin (skin exfoliation)
- Flushing or pallor (pale skin)
- Phlebitis (inflamed veins)
ANTHIM can cause serious side effects, including: Serious allergic reactions. Tell your healthcare provider right away if you have rash, hives, itching, cough, hoarse voice, shortness of breath, cyanosis, dizziness or chest discomfort while receiving ANTHIM.
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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:
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C–8°C).
Do not freeze. Do not shake.
Store in the original packaging in order to protect from light.
If you want more information about ANTHIM:
- 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website <website>, or by calling 1-800-<phone number>.
This information is current up to the time of the last revision date shown below, but more current information may be available from the manufacturer.