1- What is Alsava?
Alsava contains the active ingredient edaravone. Edaravone is a free radical scavenger and neuroprotective agent with antioxidant properties.
2- Alsava Mechanism of Action
Edaravone mechanism of action in suppressing progression of amyotrophic lateral sclerosis (ALS) is not completely clear. Edaravone is theorized to decrease effects of oxidative stress (free radicals), and in ALS patients inhibits cell membrane injury due to free radicals.
3- Alsava Indications
Edaravone is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).
4- Alsava Dosage and Administration
Recommended dose for ALS patients by IV infusion is 60 mg over 60 minutes according to the following treatment plan (given the cycle of treatment for 28 days in two 14-day periods).
Initial Treatment Cycle:
Administer 60 mg (two vials) as an IV infusion over 60 minutes once a day for 14 days, followed by a 14-day drug-free period.
Subsequent Treatment Cycle:
Administer 60 mg (two vials) as an IV infusion over 60 minutes once a day on 10 of 14 days, followed by a 14-day drug-free period.
Administration of a single dose:
Two (2) 30 mg vials (60 mg in total) as an IV infusion successively. Infusion speed should be checked to be 1 mg per minute and the total time of infusion for two (2) vials should be 60 minutes.
Before infusion, each vial should be diluted to 100 ml by physiological saline (sodium chloride 0.9% injectable solution). After diluting the vials, the infusion speed should be 3.33 ml per minute.
Reminder: Discontinue infusion upon the first observation of any signs and symptoms indicating hypersensitivity reactions.
5- Drug Form and Strength
Alsava is available in glass vials containing 30 mg of edaravone in 20 ml clear, colorless, aqueous, concentrated solution administered by IV infusion after dilution.
6- Warnings and Precautions
hypersensitivity reactions
Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postmarketing reports with edaravone.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue edaravone, treat per standard of care, and monitor until the condition resolves.
- Sulfite Allergic Reactions
Alsava contain sodium bisulfite, a sulfite that may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity occurs more frequently in asthmatic than non-asthmatic people.
Contraindications
Alsava is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in this product. Hypersensitivity reactions and anaphylactic reactions have occurred.
7- Adverse Reactions
Bruise
Abnormal gait
Common (1-10%):
Dermatitis
Eczema
Tinea
Glycosuria
Headache
Dyspnea
Hypoxia
Respiratory failure
Less common (<1%):
Anaphylactic shock
Hypersensitivity reactions
In case of any reactions while using Alsava, contact your doctor, pharmacist or Patient-Care-Line at Zistdaru Danesh Co.
8- Alsava Drug Interactions
There are currently no significant drug interactions with edaravone. However, in order to prevent the occurrence of drug interactions, be sure to tell your doctor about your medication before you start taking this drug.
9- Use in Specific Populations
Pregnancy
There are no adequate data on the developmental risk associated with the use of Alsava in pregnant women.
Lactation
There are no data on the presence of edaravone in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.
Pediatrics Use
Safety and efficacy of edaravone in children still have not been established.
Geriatric Use
No age effect on edaravone pharmacokinetics has been found.
Renal impairment
Currently the effect of renal impairment on edaravone pharmacokinetic factors has not been proven. Since renal impairment is not expected to greatly affect drug efficacy or cause drug adverse reactions, adjusting the dose in patients with renal impairment is not essential.
Hepatic impairment
Currently the effect of hepatic impairment on edaravone pharmacokinetic factors has not been proven. In mild to moderate hepatic impairment there is no need to adjust the drug dose. There is currently no study available on drug use in patients with severe hepatic impairment.
10- Alsava Storage
- Store below 30ºC and protect from light.
- Keep in original container before use.
11- D.Nurse-Patient Helpline Team
You can contact Drugs Expert Consultation Center at 0935 220 3041-4 to get answers to your inquiries and also get to know nursing support centers in your city. Expert Consultation Center is always ready to answer the questions of our valued customers.
