biopharmaceuticals Zistdaru Danesh 

alsava

ALSAVA

General description

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.

Important Things To Know

On this page you read

1- What is Alsava?

Alsava contains the active ingredient edaravone.


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

There have been cases of hypersensitivity reactions (including blushing, rash, erythema) and/or signs of anaphylactoid shock in Edaravone users.

Sulfite Allergic Reactions

 Alsava contains sodium metabisulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms or less severe asthmatic episodes in susceptible people. Sulfite sensitivity occurs more frequently in asthmatic people.In cases such above reactions are observed, discontinue infusion immediately and the patient will be treated until the symptoms are resolved.

Contraindications

In case of history of hypersensitivity reactions to edaravone or any of the excipients of this product, its use is not allowed. See end of this leaflet (Section Alsava Composition) for a complete list of ingredients in Alsava.


7- Adverse Reactions

* Very Common (more than and equal to 10 percent of patient population)

CNS: gait disturbance

blood: contusion

* Common (1 to 10 percent of patient population)
  • CNS: headache
  • skin: skin inflammation, eczema, Tinea infection
  • metabolism: glycosuria
  • respiratory: shortness of breath, hypoxia respiratory failure
* Less common (less than 1 percent of patient population)

anaphylactoid shock, hypersensitivity reactions

In case of any reactions while using edaravone, 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 is insufficient data on the use of edaravone in pregnant women.

Based on the results of animal studies, it is not recommended to use this drug in pregnancy.

*Nursing

Since there is no data regarding the amount of edaravone excreted in mother milk and the consequent risks in newborns, the use of this drug in nursing is not recommended.

*Pediatrics

Safety and efficacy of edaravone in children still have not been established.

*Geriatrics

According to studies, efficacy of edaravone in the elderly is similar to other adults.

*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.
  • Keep the medicine out of sight and reach of the children.

  • 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.