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Revolade | Promacta | Eltrombopag by Everest Pharmaceuticals Bangladesh is used to treat chronic immune (idiopathic) thrombocytopenia (ITP) or chronic hepatitis C virus (HCV).

Elopag is alternative of Promacta by Novartis. Eltrombopag belongs to a group of drugs called thrombopoietin receptor agonist from Everest Pharmaceuticals, which is the biggest pharmaceutical company in Bangladesh.

Therapeutic Class

Haemostatic drugs

Pharmacology

Eltrombopag is an orally bioavailable, small-molecule TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor. Eltrombopag is a stimulator of STAT and JAK phosphorylation. Unlike recombinant TPO or romiplostim.

It should be noted that when given to patients with aplastic anemia, other lineages besides platelet count were increased, suggesting that either eltrombopag enhanced the effect of TPO in vivo; or there is a yet uncovered mechanism of action at work.

Dosage & Administration

Chronic Immune (Idiopathic) Thrombocytopenia-

Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag / Promacta at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A,B,C).

For patients of East Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A,B,C), consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily. Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily.

Chronic Hepatitis C-associated Thrombocytopenia-

Initiate Eltrombopag at a dose of 25 mg once daily. Monitoring and Dose Adjustment: Adjust the dose of Eltrombopag in 25-mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy.

During antiviral therapy, adjust the dose of Eltrombopag / Promacta to avoid dose reductions of Peginterferon. Monitor CBCs with differentials, including platelet counts, weekly during antiviral therapy until a stable platelet count is achieved.

Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag / Promacta.

Severe Aplastic Anemia-

• Initiate Eltrombopag at a dose of 50 mg once daily. For patients with severe aplastic anemia of East Asian ancestry or those with mild, moderate or severe hepatic impairment (Child-Pugh Class A,B,C), initiate Eltrombopag at a reduced dose of 25 mg once daily.

Interaction

Take Eltrombopag / Promacta at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids, calcium-rich foods and mineral supplements.

Contraindications

There are no contraindications for Eltrombopag / Promacta.

Side Effects

The most common side effects of Eltrombopag / Promacta in adults when used to treat chronic ITP are: In adult patients with ITP, the most common adverse reactions (greater than or equal to 5% and greater than placebo) were: nausea, diarrhea.

In pediatric patients age 1 year and older with ITP, the most common adverse reactions (greater than or equal to 10% and greater than placebo) were upper respiratory tract infection and nasopharyngitis.

Pregnancy & Lactation

Pregnancy Category C. There are no adequate and well controlled studies of Eltrombopag / Promacta usein pregnancy. In animal reproduction and developmental toxicity studies, there was evidence ofembryolethality and reduced fetal weights at maternally toxic doses.

Nursing Mothers: It is not known whether Eltrombopag / Promacta is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Eltrombopag.

Precautions & Warnings

Hepatotoxicity: Monitor liver function before and during therapy.

Thrombotic or Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving Eltrombopag / Promacta. Monitor platelet counts regularly.

Use in Special Populations

Pediatric Use:The safety and efficacy of Eltrombopag in pediatric patients 1 year and older with chronic ITP were evaluated in two double-blind, placebo-controlled. The pharmacokinetics of Eltrombopag has been evaluated in 168 pediatric patients 1 year and older with ITP dosed once.

The safety and efficacy of Eltrombopag / Promacta in pediatric patients younger than 1 year with ITP have not yet been established.

Geriatric Use: Of the 106 patients in two randomized clinical trials of Eltrombopag 50 mg in chronic ITP, 22% were 65 years of age and over, while 9% were 75 years of age and over. In the two randomized clinical trials of Eltrombopag in patients with chronic hepatitis C and thrombocytopenia.

No overall differences in safety or effectiveness were observed between these patients and younger patients in the placebo-controlled trials, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment: Hepatic impairment influences the exposure of Eltrombopag / Promacta. Reduce the initial dose of Eltrombopag in patients with chronic ITP (adult and pediatric patients 6 years and older only) or severe aplastic anemia who also have hepatic impairment.

Renal Impairment: No adjustment in the initial dose of Eltrombopag is needed for patients with renal impairment. Closely monitor patients with impaired renal function when administering Eltrombopag.

Overdose Effects

In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications.

In one report, a subject who ingested 5,000 mg of Eltrombopag / Promacta had a platelet count increase to a maximum of 929 x 109/L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations and fatigue.

The patient was treated with gastric lavage, oral Lactulose, Intravenous fluids, Omeprazole, Atropine, Furosemide, Calcium, Dexamethasone, andPlasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months follow-up.

In case of an overdose, consider oral administration of a metal cation-containing preparation, such as Calcium, Aluminum, or Magnesium preparations to chelate Eltrombopag / Promacta  and thus limit absorption. Closely monitor platelet counts.

Storage Conditions

Store in a cool and dry place, away from light and moisture. Keep out of the reach of children.