edaravone

REMS

Amyotrophic lateral sclerosis (ALS).

Contraindicated in:

Hypersensitivity;
Sulfite allergy.

Use Cautiously in:

Severe renal impairment;
OB: Safety not established in pregnancy;Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Derm: contusion, dermatitis, eczema, fungal infection (tinea)

GU: glycosuria

Neuro: gait abnormality, headache

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Drug-drug:

None known.

(Generic available)

Oral suspension: 105 mg/5 mL
Premixed infusion: 30 mg/100 mL; 60 mg/100 mL

PO (Adults ): 105 mg once daily in the morning on an empty stomach (after overnight fasting) for 14 days, followed by a drug-free period of 14 days. Each subsequent cycle should consist of 105 mg once daily in the morning on an empty stomach (after overnight fasting) for 10 days out of 14 days, followed by a drug-free period of 14 days.
IV (Adults ): 60 mg once daily for 14 days, followed by a drug-free period of 14 days. Each subsequent cycle should consist of 60 mg once daily for 10 days out of 14 days, followed by a drug-free period of 14 days.

~~Radicava,~~ Radicava ORS

Unknown.

Therapeutic effects:

Improved functional ability.

Therapeutic Classification: agents for amyotrophic lateral sclerosis

Absorption: IV administration results in complete bioavailability. 57% bioavailability of oral suspension (absorption significantly ↓ when taken with food).

Distribution: Well distributed to tissues.

Protein Binding: 92%.

Metabolism/Excretion: Metabolized via sulfation and glucuronidation into inactive metabolites. Primarily eliminated in urine (1% as unchanged drug).

Half-Life: IV: 4.5–6 hr. Oral suspension: 4.5–9 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	1 hr	unknown
PO	unknown	30 min	24 hr

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Instruct patient to notify health care professional immediately if signs and symptoms of hypersensitivity or allergic reactions (hives; swelling of lips, tongue, or face; fainting; breathing problems; dizziness; itching; wheezing) occur.
Instruct patient to notify health care professional of persistent headache or skin irritation.
Advise patient to measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug. Do not use household measurements.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

e-DAR-a-vone

NDC Code

0781- Sandoz Inc
- 0781-3527- Edaravone
  - 0781-3527-20- 2 BAG in 1 CARTON (0781-3527-20) / 100 mL in 1 BAG (0781-3527-94)

14501- MSN Laboratories Private Limited
- 14501-0100-
  - 14501-0100-4- 25 kg in 1 DRUM (14501-0100-4)

16436- Medichem Manufacturing (Malta) Ltd.
- 16436-0120-
  - 16436-0120-0- 75 kg in 1 DRUM (16436-0120-0)

39822- XGen Pharmaceuticals DJB, Inc.
- 39822-4500- edaravone
  - 39822-4500-2- 2 VIAL, SINGLE-DOSE in 1 CARTON (39822-4500-2) / 100 mL in 1 VIAL, SINGLE-DOSE (39822-4500-1)

39822- XGen Pharmaceuticals DJB, Inc.
- 39822-4510- edaravone
  - 39822-4510-1- 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-4510-1) / 100 mL in 1 VIAL, SINGLE-DOSE

53069- Quimica Sintetica S.A.
- 53069-1070-
  - 53069-1070-5- 5 kg in 1 DRUM (53069-1070-5)

53104- Cipla Ltd.
- 53104-7744-
  53104-7744-1- 25 kg in 1 DRUM (53104-7744-1)

53296- Medichem S.A.
- 53296-0120-
  53296-0120-0- 75 kg in 1 DRUM (53296-0120-0)

58032- Neuland Laboratories Limited
- 58032-2035-
  58032-2035-0- 1 kg in 1 DRUM (58032-2035-0)

64552- Interquim, S.A.
- 64552-4098-
  64552-4098-1- 25 kg in 1 CARTON (64552-4098-1)

66794- Piramal Critical Care Inc.
- 66794-259- Edaravone
  66794-259-64- 2 POUCH in 1 CARTON (66794-259-64) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

68083- Gland Pharma Limited
- 68083-500- edaravone
  - 68083-500-02- 2 POUCH in 1 CARTON (68083-500-02) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

68083- Gland Pharma Limited
- 68083-501- edaravone
  - 68083-501-01- 1 POUCH in 1 CARTON (68083-501-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

69037- Honour Lab Limited
- 69037-0060-
  - 69037-0060-1- 10 kg in 1 DRUM (69037-0060-1)

70510- Mitsubishi Tanabe Pharma America, Inc.
- 70510-2171- RADICAVA
  70510-2171-2- 2 BAG in 1 CARTON (70510-2171-2) / 100 mL in 1 BAG (70510-2171-1)

70510- Mitsubishi Tanabe Pharma America, Inc.
- 70510-2191-
  - 70510-2191-1- 1 BAG in 1 DRUM (70510-2191-1) / 1 BAG in 1 BAG / 10 kg in 1 BAG

70510- Mitsubishi Tanabe Pharma America, Inc.
- 70510-2321- RADICAVA ORS
  70510-2321-2- 2 CARTON in 1 CARTON (70510-2321-2) / 1 KIT in 1 CARTON (70510-2321-1) * 1 BOTTLE in 1 KIT (70510-2323-1) / 35 mL in 1 BOTTLE

70510- Mitsubishi Tanabe Pharma America, Inc.
- 70510-2322- RADICAVA ORS
  - 70510-2322-1- 1 KIT in 1 CARTON (70510-2322-1) * 50 mL in 1 BOTTLE (70510-2324-1)

71796- Dr. Reddys Laboratories Limited
- 71796-017-
  - 71796-017-00- 1 kg in 1 DRUM (71796-017-00)

72643- SOLARA ACTIVE PHARMA SCIENCES LIMITED
- 72643-034-
  72643-034-01- 1 kg in 1 DRUM (72643-034-01)

72643- SOLARA ACTIVE PHARMA SCIENCES LIMITED
- 72643-034-
  72643-034-11- 2 kg in 1 DRUM (72643-034-11)

73435- Biophore India Pharmaceuticals Pvt. Ltd
- 73435-008-
  73435-008-11- 25 kg in 1 DRUM (73435-008-11)

81298- Long Grove Pharmaceuticals, LLC
- 81298-7050- Edaravone
  81298-7050-3- 2 BAG in 1 CARTON (81298-7050-3) / 100 mL in 1 BAG (81298-7050-1)

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆