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M-AMBRISENTAN is a brand name for Ambrisentan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: M-AMBRISENTAN (ambrisentan tablets) is indicated for treatment of idiopathic (‘primary’) pulmonary arterial hypertension (IPAH) and pulmonary arterial hypertension (PAH) associated with connective tissue disease in adult patients with WHO functional class II or III symptoms. M-AMBRISENTAN is also indicated for…
Verbatim from this product's HC label. Tap a section to expand.
). • Patients with baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT)) >3 x ULN (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, and 4 DOSAGE AND ADMINISTRATION).
• Patients with idiopathic pulmonary fibrosis (IPF), with or without pulmonary hypertension. 1 Dosing Considerations • Treatment should only be initiated by a physician experienced in the treatment of PAH. • Assess liver function before starting M-AMBRISENTAN (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, and Monitoring and Laboratory Tests).
1 Pregnant Women). • M-AMBRISENTAN is contraindicated in patients with severe hepatic impairment and those with baseline AST or ALT >3x ULN. Patients with ALT/AST levels >2 x ULN were not included in a clinical trial studying co-administration of ambrisentan with tadalafil.
3 Pharmacokinetics, and Special Populations and Conditions, Hepatic Insufficiency). • Patients with PAH associated with connective tissue disease may require 10 mg M-AMBRISENTAN for optimal efficacy. Consider increasing the dose to 10 mg M-AMBRISENTAN providing the 5 mg dose is well tolerated (see 8 ADVERSE REACTIONS).
2 Recommended Dose and Dosage Adjustment M-AMBRISENTAN should be initiated at a dose of 5 mg once daily. Additional benefit may be obtained by increasing the dose to 10 mg once daily. When used in initial combination with tadalafil, the dose of tadalafil should be uptitrated from 20 mg to 40 mg once daily 4 weeks after initiation and M-AMBRISENTAN should be uptitrated from 5 mg to 10 mg after another 4 weeks, if well tolerated (see 14 CLINICAL TRIALS).
The maximum recommended daily dose is 10 mg. 4 Drug-Drug Interactions, Cyclosporine A). M-AMBRISENTAN can be administered with or without food. Safety and efficacy of ambrisentan tablets have not been established in patients under 18 years of age.
Health Canada has not authorized an indication for pediatric use (see 16 NON- CLINICAL TOXICOLOGY). No dose adjustment is required in patients aged 65 years and over. In clinical monotherapy studies, peripheral edema was reported as dose dependent and more common in patients ≥65 years of age.
Renal metabolism and excretion of M-AMBRISENTAN is minimal, so dose adjustment is unlikely to be required in patients with renal impairment. 5 Missed Dose If a dose of M-AMBRISENTAN is missed, the patient should be advised to take it as soon as they remember, and then continue with the next dose at the regular interval.
). 2 Recommended Dose and Dosage Adjustment M-AMBRISENTAN should be initiated at a dose of 5 mg once daily. Additional benefit may be obtained by increasing the dose to 10 mg once daily. When used in initial combination with tadalafil, the dose of tadalafil should be uptitrated from 20 mg to 40 mg once daily 4 weeks after initiation and M-AMBRISENTAN should be uptitrated from 5 mg to 10 mg after another 4 weeks, if well tolerated (see 14 CLINICAL TRIALS).
The maximum recommended daily dose is 10 mg. 4 Drug-Drug Interactions, Cyclosporine A). M-AMBRISENTAN can be administered with or without food. Safety and efficacy of ambrisentan tablets have not been established in patients under 18 years of age.
Health Canada has not authorized an indication for pediatric use (see 16 NON- CLINICAL TOXICOLOGY). No dose adjustment is required in patients aged 65 years and over. In clinical monotherapy studies, peripheral edema was reported as dose dependent and more common in patients ≥65 years of age.
Renal metabolism and excretion of M-AMBRISENTAN is minimal, so dose adjustment is unlikely to be required in patients with renal impairment. 5 Missed Dose If a dose of M-AMBRISENTAN is missed, the patient should be advised to take it as soon as they remember, and then continue with the next dose at the regular interval.
Two doses should not be taken at the same time to make up for a missed dose. 5 OVERDOSAGE In healthy volunteers, single doses of 50 and 100 mg (5 to 10 times the maximum M-AMBRISENTAN (ambrisentan tablets) Product Monograph Page 6 of 48 recommended dose) were associated with headache, flushing, dizziness, nausea, and nasal congestion.
Due to the mechanism of action of ambrisentan tablets, an overdosage of M-AMBRISENTAN could potentially result in hypotension. In the case of pronounced hypotension, active cardiovascular support may be required. No specific antidote is available.
, Hepatic/Biliary/Pancreatic, and 4 DOSAGE AND ADMINISTRATION). • Patients with baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT)) >3 x ULN (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, and 4 DOSAGE AND ADMINISTRATION).
• Patients with idiopathic pulmonary fibrosis (IPF), with or without pulmonary hypertension. 1 Dosing Considerations • Treatment should only be initiated by a physician experienced in the treatment of PAH. • Assess liver function before starting M-AMBRISENTAN (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, and Monitoring and Laboratory Tests).
1 Pregnant Women). • M-AMBRISENTAN is contraindicated in patients with severe hepatic impairment and those with baseline AST or ALT >3x ULN. Patients with ALT/AST levels >2 x ULN were not included in a clinical trial studying co-administration of ambrisentan with tadalafil.
3 Pharmacokinetics, and Special Populations and Conditions, Hepatic Insufficiency). • Patients with PAH associated with connective tissue disease may require 10 mg M-AMBRISENTAN for optimal efficacy. Consider increasing the dose to 10 mg M-AMBRISENTAN providing the 5 mg dose is well tolerated (see
M-AMBRISENTAN is contraindicated in: • Patients with a known or suspected hypersensitivity to M-AMBRISENTAN or any of the ingredients in the formulation (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). 1 Pregnant Women). 2 Breast-feeding).
• Patients with severe hepatic impairment (with or without cirrhosis) (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, and
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Two doses should not be taken at the same time to make up for a missed dose.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Packaging M-AMBRISENTAN 5 mg film-coated tablets are pale pink, square, convex, and debossed with “5” on one side, plain on the other side.
M-AMBRISENTAN 10 mg film-coated tablets are pink, oblong, biconvex, and debossed with “10” on one side, plain on the other side. M-AMBRISENTAN tablets are available in blister packs of 30 (3 x 10’s) tablets. 7 WARNINGS AND PRECAUTIONS Carcinogenesis and Mutagenesis There are no human data available (see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity and Genotoxicity).
Driving and Operating Machinery There have been no studies to investigate the effect of ambrisentan tablets on driving performance or the ability to operate machinery. Further, a detrimental effect on such activities cannot be predicted from the pharmacology of the active substance.
Fluid Retention Peripheral edema (fluid retention) has been observed with endothelin receptor antagonists (ERAs) including ambrisentan tablets. Peripheral edema may also be a clinical consequence of PAH. Ambrisentan tablets induced a dose-dependent increased incidence of mild to moderate peripheral edema (see 8 ADVERSE REACTIONS).
Route of Administration Dosage Form / Composition / Strength Non-medicinal Ingredients Oral Tablet, 5 mg and 10 mg Croscarmellose sodium, FD&C Red #40 aluminum lake, lactose monohydrate, lecithin (soya), magnesium stearate, microcrystalline cellulose, polyethylene glycol /macrogol, polyvinyl alcohol, talc, and titanium dioxide.
2 Clinical Trial Adverse Reactions, Table 2). If patients have pre-existing fluid overload, this should be managed as clinically appropriate prior to starting M-AMBRISENTAN. If clinically significant peripheral edema develops during therapy with M-AMBRISENTAN, with or without associated weight gain, further evaluation should be undertaken to determine the cause, such as the use of M-AMBRISENTAN or the existence of underlying heart failure.
The possible need for specific treatment or discontinuation of M-AMBRISENTAN therapy should also be evaluated. Fluid retention/peripheral edema is more common during therapy with ambrisentan tablets plus tadalafil than with either ambrisentan tablets or tadalafil alone.
Hematologic The development of drug-related decreases in hemoglobin concentration and hematocrit has been associated with administration of endothelin receptor antagonists and was observed in clinical studies with ambrisentan tablets in monotherapy.
There have been cases where this has resulted in anemia requiring transfusion. These decreases were generally observed within the first few weeks of treatment with ambrisentan tablets, and stabilized thereafter. Anemia is more common during therapy with ambrisentan tablets plus tadalafil than with either ambrisentan tablets or tadalafil alone (see 8 ADVERSE REACTIONS).
Initiation of M-AMBRISENTAN is not recommended for patients with clinically significant anemia (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests). Hepatic/Biliary/Pancreatic Liver function abnormalities have been associated with pulmonary arterial hypertension.
Hepatic enzyme elevations potentially related to therapy have been observed with endothelin receptor antagonists (ERAs). Therefore, hepatic function should be evaluated prior to initiation of M-AMBRISENTAN. Monitor liver function as clinically indicated for patients with normal liver function or mild hepatic impairment.
Initiation of M-AMBRISENTAN is contraindicated for patients with […]