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Ponaxen 15 Ponatinib Hydrochloride INN equivalent to Ponatinib 15 mg

22500/Bottle Get Latest Price

Product Brochure
Strength15 mg
FormTablet
Usage/ApplicationPersonal
CompostionPONATINIB
Prescription/Non prescriptionPrescription
brandEVAREST PHARMACEUTICALS
Country of OriginMade in India

Description

Ponaxen-15/45mg-Ponatinib is a type of multi-targeted tyrosine-kinase inhibitor. Bangladeshi pharmaceutical Everest is the manufacturer of Ponaxen.

It is primarily used for treating chronic myeloid leukemia (CML) and Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).

The medicine targets CML with the T315I mutation, which is generally resistant to current therapies such as imatinib. Due to its effectiveness against these tumors, Ponaxen has proven to be a valuable treatment option.

Ponaxen-15/45mg-Ponatinib FDA Approval and Indications

Ponaxen-15/45mg-Ponatinib is a tyrosine kinase inhibitor, received approval from the US FDA in 2012.

The approval was for patients with chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL). Who were either unable to tolerate or resistant to other treatments.

FDA gave full approval of Ponatinib in 2016 and updated it’s label. The updated label included patients with CML, chronic phase, accelerated phase, or blast phase. The label also included Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL).

Ponatinib Mechanism of Action

Ponaxen-15/45mg-Ponatinib is a BCR-ABL tyrosine kinase inhibitor, that specifically targets BCR-ABL. BCR-ABL is an abnormal tyrosine kinase found in both CML and Ph+ ALL.

CML is a condition that is characterized by excessive production of white blood cells due to a genetic abnormality. Which can lead to aggressive phases like accelerated or blast crises.

Ph+ ALL, on the other hand, is a subtype of acute lymphoblastic leukemia (ALL). That carries the Ph+ chromosome, which produces BCR-ABL.

Both of these diseases express the BCR-ABL protein, which makes them potentially susceptible to ponatinib treatment. BCR-ABL is detected in 95% of patients with CML.

Dosage and Administration

The recommended dose of iclusig/Ponatinib is 45 mg administered orally once daily. Continue treatment as long as the patient does not show evidence of disease progression or unacceptable toxicity. Ponaxen can be taken with or without foods. Tablets should be swallowed whole.

Dosage adjustments

  • Hepatic impairment:

Reduce the starting dose to 30 mg once a day in patients with pre-existing hepatic impairment (Child-Pugh A, B, or C).

  • Concomitant use of strong CYP3A inhibitors:

Reduce the dose to once a day in patients who are taking strong CYP3A inhibitors.

  • Adverse reactions:

Dose reductions may be necessary for adverse reactions, such as blood clots, arterial occlusion, heart problems, and liver damage.

Dose reduction schedule

  • First reduction: 30 mg PO q Day
  • Second reduction: 15 mg PO q Day
  • Third reduction: 10 mg PO q Day
  • Unable to tolerate 10 mg/day: Permanently discontinue

Monitoring

Doctor should monitor the patients closely for adverse reactions including blood clots, arterial occlusion, heart problems, and liver damage.

Complete blood counts (CBCs) should be performed at least weekly for the first 2 months of therapy and then monthly thereafter.

Liver function tests (LFTs) should be performed at least monthly for the first 3 months of therapy and then every 3 months thereafter.

Storage

Ponaxen tablets should be stored at room temperature (15-30°C) in a dry place.


Ponaxen 45 Ponatinib Hydrochloride INN equivalent to Ponatinib 45 mg

67000/Bottle Get Latest Price

Product Brochure
Strength45 mg
FormTablet
Usage/ApplicationPersonal
Packaging Size30 Tablets
CompostionPonatinib Hydrochloride INN equivalent to Ponatinib 45 mg
Prescription/Non prescriptionPrescription
BRANDEVAREST PHARMACEUTICALS
Country of OriginMade in India

IndicationsPonaxen is a kinase inhibitor indicated for the:

  • Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
  • Treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
PharmacologyPonatinib is a kinase inhibitor. Ponatinib inhibited the in vitro tyrosine kinase activity of ABL and T315I mutant ABL with IC 50 concentrations of 0.4 nM and 2.0 nM, respectively. Ponatinib inhibited the in vitro activity of additional kinases with IC 50 concentrations between 0.1 nM and 20 nM, including members of the VEGFR, PDGFR, FGFR, EPH receptors and SRC families of kinases, and KIT, RET, TIE2, and FLT3. Ponatinib inhibited the in vitro viability of cells expressing native or mutant BCR-ABL, including T315I. In mice, treatment with ponatinib reduced the size of tumors expressing native or T315I mutant BCR-ABL when compared to controls.Dosage & AdministrationRecommended dose: 45 mg taken orally once daily with or without food

Hepatic Impairment: 30 mg orally once daily. Modify or interrupt dosing for hematologic and non-hematologic toxicity
ContraindicationsNoneSide EffectsThe most common non-hematologic adverse reactions (≥20%) were, abdominal pain, rash, constipation, headache, dry skin, arterial occlusion, fatigue, hypertension, pyrexia, arthralgia, nausea, diarrhea, lipase increased, vomiting, myalgia and pain in extremity.Pregnancy & LactationBased on its mechanism of action and findings in animals, Ponatinib can cause fetal harm when administered to a pregnant woman. There are no available data on Ponatinib use in pregnant women. In animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at doses lower than human exposures at the recommended human dose. Advise pregnant women of the potential risk to a fetus.

There is no data on the presence of ponatinib in human milk, the effects on the breastfed infant or on milk production.Use in Special PopulationsPediatric Use: Safety and effectiveness have not been established in pediatric patients.Therapeutic ClassTyrosine Kinase InhibitorStorage ConditionsStore Ponaxen at room temperature between 20° C to 25° C

Enzanamo Enzalutamid 40mg

11000/Stripe Get Latest Price

Strength40 mg
FormTablet
Usage/ApplicationPersonal
CompostionEnzalutamid 40mg
Prescription/Non prescriptionNon prescription
Country of OriginMade in India

Enzanamo Enzalutamide 40mg Capsule is used in the treatment of cancer of the prostate gland. It may be also used to treat other conditions, as determined by the doctor. It works by blocking the effects of male hormones such as testosterone.

Enzamide 40mg Capsule should be taken with or without food, preferably at a fixed time every day. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.

Niranib Niraparib Tosylate Monohydrate equivalent to Niraparib 100 Mg

30999/Bottle Get Latest Price

Strength100 mg
FormTablet
Usage/ApplicationPersonal
CompostionNIRAPARIB
Prescription/Non prescriptionPrescription
BRANDEVAREST PHARMACEUTICALS
Country of OriginMade in India

IndicationOvarian CancerAdministrationMay take with or without food Initiate niraparib no later than 8 weeks after their most recent platinum-containing regimen Instruct patient to take dose at about the same time each dayAdult DoseOvarian Cancer Indicated for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy 300 mg PO qDay; continue until disease progression or unacceptable toxicity Hepatic impairment Mild: No dose adjustment required Moderate or severe: Not studiedRenal DoseRenal impairment Mild-to-moderate (CrCl ?30 mL/min): No dose adjustment required Severe or ESRD: Not studiedMode of ActionPoly (ADP-ribose) polymerase (PARP) inhibitor; niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage, apoptosis, and cell deathPrecautionMyelodysplastic syndrome/acute myeloid leukemia (MDS/AML), including cases with fatal outcome, reported; discontinue drug if MDS/AML is confirmed May cause bone marrow suppression resulting in hematologic toxicities (eg, thrombocytopenia, anemia, neutropenia); do not initiate until patients have recovered from hematological toxicities caused by previous chemotherapy (grade ≤1); monitor complete blood cell counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time (also see Dosage Modifications) Hypertension and hypertensive crisis reported; monitor BP and HR monthly for the first year and periodically thereafter during treatment; medically manage hypertension with antihypertensive medications and niraparib dose adjustment Based on its mechanism of action, can cause fetal harm if administered to a pregnant womanSide Effect>10% Nausea (74%) Thrombocytopenia (61%) Fatigue/asthenia (57%) Anemia (50%) Constipation (40%) Vomiting (34%) Abdominal pain/distention (33%) Neutropenia (30%) Thrombocytopenia, grades 3 or 4 (29%) Insomnia (27%) Headache (26%) Anemia, grades 3 or 4 (25%) Nasopharyngitis (23%) Rash (21%) Hypertension (20%) Neutropenia, grades 3 or 4 (20%) Mucositis/stomatitis (20%) Diarrhea (20%) Dyspepsia (20%) Myalgia (19%) Back pain (18%) Dyspepsia (18%) Dizziness (18%) Leukopenia (17%) Cough (16%) UTI (13%) Arthralgia (13%) Anxiety (11%) 1-10% Palpitations (10%) Dry mouth (10%) AST/ALT elevation (10%) Dysgeusia (10%) Hypertension, grade 3 or 4 (9%) Leukopenia, grades 3 or 4 (5%)Pregnancy Category NotePregnancy Niraparib has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (eg, bone marrow) A pregnancy test is recommended for females of reproductive potential prior to initiating drug Based on animal studies, may impair fertility in males of reproductive potential Contraception Advise females of reproductive potential to use effective contraception during treatment for at least 6 months following the last dose Lactation Because of the potential for serious adverse reactions in breastfed infants, advise a lactating woman not to breastfeed during treatment and for 1 month after receiving the final dose

Alkixen Crizotinib 250 mg

24000/Bottle Get Latest Price

Product Brochure
FormTablet
Usage/ApplicationPersonal
CompostionCrizotinib
Prescription/Non prescriptionNon prescription
BrandEverest

Alkixen, containing Crizotinib as its International Nonproprietary Name (INN), is primarily prescribed to treat non-small cell lung cancer (NSCLC), particularly in patients with specific genetic mutations like ALK-positive NSCLC. Acting as a potent inhibitor of ALK, Crizotinib targets the ALK protein commonly found in NSCLC cells, thereby hindering their proliferation. The standard dosage of Alkixen typically involves taking 250 mg orally twice daily, preferably with food. Possible side effects may include nausea, vomiting, diarrhea, fatigue, and visual disturbances. To effectively manage potential adverse effects and ensure favorable treatment outcomes, it is advisable to undergo regular medical evaluations and close monitoring during Alkixen therapy.

Mavixen Glecaprevir 100 mg/Pibrentasvir 40 mg

94000/Bottle Get Latest Price

Strength100 mg / 40 mg
Packaging TypeBottle
CompositionGLECAPREVIR &PIBRENTASVIR
BrandEVAREST PHARMACEUTICALS
ManufacturerEVAREST PHARMACEUTICALS
Prescription/Non prescriptionPrescription
FormTablet

IndicationChronic Hepatitis CAdministrationTake with food at the same time once dailyAdult DoseChronic Hepatitis C Treatment-naïve adults and adolesents with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with compensated cirrhosis Treatment-experienced patients with HCV genotype 1 who have been previously treated with a regimen containing either an NS5A inhibitor or an NS3/4A protease inhibitor, but not both 3 tablets (ie, 300 mg/120 mg total dose) PO once daily with food Recommended duration for treatment-naïve patients Genotypes 1-6, no cirrhosis: 8 wk Genotypes 1-6, compensated cirrhosis (Child-Pugh A): 12 wk Recommended duration for treatment-experienced patients No cirrhosis Genotype 1 and NS5A inhibitor prior treatment: 16 wk Genotype 1 and NS3/4A protease inhibitor prior treatment: 12 wk Genotypes 1, 2, 4, 5, or 6 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 8 wk Genotype 3 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 16 wk Compensated cirrhosis (Child-Pugh A) Genotype 1 and NS5A inhibitor prior treatment: 16 wk Genotype 1 and NS3/4A protease inhibitor prior treatment: 12 wk Genotypes 1, 2, 4, 5, or 6 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 12 wk Genotype 3 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 16 wk Hepatic impairment Mild (Child-Pugh A): No dosage adjustment required Moderate (Child-Pugh B): Not recommended Severe (Child-Pugh C): ContraindicatedRenal DoseRenal impairment Mild, moderate, or severe, including patients on dialysis: No dosage adjustment requiredContraindicationSevere hepatic impairment (Child-Pugh C) Coadministration with atazanavir or rifampinMode of ActionGlecaprevir: HCV NS3/4A protease inhibitor; necessary for the proteolytic cleavage of the HCV-encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication Pibrentasvir: HCV NS5A inhibitor; essential for viral RNA replication and virion assemblyPrecautionHepatitis B virus reactivation in patients coinfected with HCV/HBV may occurSide Effect>10% Headache (9-17%) Fatigue (11-14%) Nausea (6-12%) 1-10% Diarrhea (3-7%) Increased bilirubin, ≥2x ULN (3.5%) Pruritus (7%)Pregnancy Category NotePregnancy No adequate human data are available to establish whether or not glecaprevir/pibrentasvir poses a risk to pregnancy outcomes Animal studies No adverse developmental effects were observed when glecaprevir and pibrentasvir were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommended dose Lactation Unknown if distributed in human breast milk When administered to lactating rodents, glecaprevir and pibrentasvir were present in milk, without effect on growth and development observed in the nursing pups Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal conditionInteractionCoadministration is contraindicated with rifampin or atazanavir Coadministration is not recommended with carbamazepine, efavirenz, or St John’s wort

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