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This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.
- This drug may increase your liver enzymes. This can lead to liver damage. Your doctor will check your liver function when you first start taking this drug and during treatment. If your liver isn’t working well, your doctor may lower your dosage or stop your treatment with this drug.
- Eltrombopag oral tablet is available as a brand-name drug. It’s not available as a generic drug. Brand name: Promacta.
- Eltrombopag comes in two forms: oral tablet and oral suspension.
- Eltrombopag oral tablet is used to treat low platelet levels due to chronic immune thrombocytopenia (ITP) or chronic hepatitis C virus infection. It’s also used to treat severe aplastic anaemia.
Eltrombopag is a prescription drug. It comes as an oral tablet and an oral suspension.
Eltrombopag oral tablet is available as the brand-name drug Promacta. It’s not available as a generic drug.
This drug may be used as part of combination therapy. This means you may need to take it with other medications.
Why it’s used
Eltrombopag is used to treat:
- Low platelet levels due to chronic immune thrombocytopenia (ITP). This is a bleeding disorder. Eltrombopag is given to people who haven’t responded well to other drugs or surgery.
- Low platelet counts due to chronic hepatitis C virus infection. This drug is used before and during treatment with the drug pegylated interferon and ribavirin.
- Severe aplastic anemia. Aplastic anaemia is when you have bone marrow failure, which results in low levels of platelets, red blood cells, and white blood cells. Eltrombopag is used in two ways for this condition:
- First-line treatment of severe aplastic anaemia. This drug can be used as the first treatment option in some cases of severe aplastic anaemia. For this use, eltrombopag is given in combination with other initial treatments.
- Treatment of refractory severe aplastic anaemia. Some cases of severe aplastic anaemia are refractory, which means the anaemia did not improve after treatment with other medications. Eltrombopag can be used alone for treating these cases of anaemia.
Eltrombopag is not used to treat myelodysplastic syndrome (MDS).
How it works
Eltrombopag belongs to a class of drugs called thrombopoietin (TPO) receptor agonists. A class of drugs is a group of medications that work similarly. These drugs are often used to treat similar conditions.
Eltrombopag works by increasing cells in your bone marrow. It causes these cells to make more platelets. This effect lowers your risk of bleeding.
Osicent 80: Each tablet contains Osimertinib Mesylate INN equivalent to Osimertinib 80 mg.
Osimertinib is a kinase inhibitor of the epidermal growth factor receptor (EGFR), which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions) at approximately 9-fold lower concentrations than wild-type. In cultured cells and animal tumour implantation models, osimertinib exhibited anti-tumour activity against non-small cell lung cancer (NSCLC) lines harbouring EGFR-mutations (T790M/L858R, L858R, T790M/exon 19 deletion, and exon 19 deletions) and, to a lesser extent, wild-type EGFR amplifications.
Osimertinib is a kinase inhibitor indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.
Dosage & Administration
80 mg orally once daily, with or without food.
The most common (>20%) adverse reactions (all grades) observed in Osimertinib-treated patients were diarrhoea (42%), rash (41%), dry skin (31%), and nail toxicity (25%). The most frequent adverse reactions that led to dose reductions or interruptions were: electrocardiogram QTc prolonged (2.2%) and neutropenia (1.9%). Serious adverse reactions reported in 2% or more patients were pneumonia and pulmonary embolus.
Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 3.3% of patients. Osimertinib should be permanently discontinued in patients diagnosed with ILD/Pneumonitis.
QTc Interval Prolongation: Electrocardiograms and electrolytes should be monitored in patients who have a history or predisposition for QTc prolongation, or those who are taking medications that are known to prolong the QTc interval. Osimertinib should be withheld then restarted at a reduced dose or permanently discontinued.
Cardiomyopathy: Occurred in 1.4% of patients. Left ventricular ejection fraction (LVEF) should be assessed before treatment and then every 3 months thereafter.
Embryo-Fetal Toxicity: Osimertinib can cause fetal harm. Females should be advised of the potential risk to the fetus and to use effective contraception during treatment with Osimertinib and for 6 weeks after the final dose. Males should be advised to use effective contraception for 4 months, after the last dose of Osimertinib.
Use in Pregnancy & Lactation
Based on its mechanism of action and animal data, Osimertinib can cause fetal harm when administered to a pregnant woman. There are no available data on Osimertinib use in pregnant women. Pregnant women should be advised of the potential risk to a fetus.
There are no data on the presence of Osimertinib in human milk, the effects of Osimertinib on the breastfed infant or on milk production. A lactating woman should be advised not to breastfeed during treatment.
The safety and effectiveness of Osimertinib in pediatric patients have not been established.
No overall differences in safety were observed between patients 65 years and older and those younger than 65 years.
Strong CYP3A Inhibitors
Concomitant administration of Osimertinib should be avoided with strong CYP3A inhibitors, including macrolide antibiotics (e.g., telithromycin), antifungals (e.g., itraconazole), antivirals (e.g., ritonavir), nefazodone, as concomitant use of strong CYP3A inhibitors may increase Osimertinib plasma concentrations. If no other alternative exists, patients should be monitored more closely for adverse reactions.
Strong CYP3A Inducers
Concomitant administration of Osimertinib should be avoided with strong CYP3A inducers (e.g., phenytoin, rifampicin, carbamazepine, St. John’s Wort) as strong CYP3A inducers may decrease Osimertinib plasma concentrations.
Osicent 80 Container Pack: Each bottle contains 30 tablets.
Osicent 80: Each box contains 1 blister strip of 10 tablets.
Panovir: Each tablet contains Sofosbuvir INN 400 mg and Velpatasvir INN 100 mg.
It is a fixed-dose combination tablet containing sofosbuvir and velpatasvir for oral administration. Sofosbuvir is a nucleotide analogue HCV NS5B polymerase inhibitor and velpatasvir is an NS5A inhibitor.
Sofosbuvir and Velpatasvir combination is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection
– without cirrhosis or with compensated cirrhosis
– with decompensated cirrhosis for use in combination with ribavirin
Dosage & Administration
The recommended dosage is one tablet (400 mg of Sofosbuvir and 100 mg of Velpatasvir) taken orally once daily. Recommended treatment regimen:
– Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A) – one tablet once daily for 12 weeks
– Patients with decompensated cirrhosis (Child-Pugh B or C) – one tablet once daily and Ribavirin for 12 weeks. The recommended dosage of Ribavirin is based on body weight (1000 mg/day for patients < 75 kg and 1200 mg/day for ≥ 75 kg, in two divided doses/day)
No dosage recommendation can be given for patients with severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2) or with ESRD, due to higher exposures of the predominant sofosbuvir metabolite.
The most common side effects of the Sofosbuvir and Velpatasvir combination include headache and tiredness. Treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (a medicine used to treat certain heart problems).
Serious symptomatic bradycardia may occur in patients taking amiodarone, particularly in patients also receiving beta-blockers, or those with underlying cardiac comorbidities and/or advanced liver disease. Coadministration of amiodarone with Sofosbuvir and Velpatasvir combination is not recommended. In patients without alternative viable treatment options, cardiac monitoring is recommended.
Use in Pregnancy & Lactation
No adequate human data are available to establish whether or not Sofosbuvir and Velpatasvir combination poses a risk to pregnancy outcomes. If Sofosbuvir and Velpatasvir combination administered with Ribavirin, the combination regimen is contraindicated in pregnant women and in men whose female partner is pregnant or going to be pregnant in the next six months.
Drugs may decrease the concentrations of sofosbuvir and/or velpatasvir: Antacids, H2-receptor antagonists, Proton-pump inhibitors etc.
Coadministration is not recommended with: topotecan, Carbamazepine, Phenytoin, Phenobarbital, Oxcarbazepine, Rifabutin, Rifampin, Rifapentine, efavirenz, Tipranavir, Ritonavir, Hypericum perforatum.
Coadministration of Sofosbuvir and Velpatasvir combination, with Rosuvastatin, Atorvastatin may significantly increase the concentration of Rosuvastatin, Atorvastatin.
If an overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose includes monitoring of vital signs as well as observation of the clinical status of the patient.
Store in a cool and dry place (preferably below 30°C). Keep out of reach of children.
Panovir Container Pack: Each bottle contains 28 tablets.
Hanover : Each box contains 1 blister strip of 6 tablets.
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