Loading…
PMS-PAZOPANIB is a brand name for Pazopanib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Metastatic Renal Cell Carcinoma pms-PAZOPANIB (pazopanib as pazopanib hydrochloride) is indicated for the treatment of patients with metastatic renal cell (clear cell) carcinoma (mRCC) as first-line systemic therapy or as second-line systemic therapy after treatment with cytokines for metastatic disease. Approval of…
Verbatim from this product's HC label. Tap a section to expand.
, Hepatic Impairment. 1 Dosing Considerations Dose modification, either an increase or decrease in dose, should be in 200 mg increments in a stepwise fashion based on individual tolerability in order to manage adverse reactions. The dose of pms-PAZOPANIB should not exceed 800 mg.
5 X ULN (with direct bilirubin >35%) and ALT elevations >2 X ULN, or who have moderate or severe hepatic impairment (Child-Pugh B and C). No formal studies have been carried out in patients with mild hepatic impairment and caution is recommended in these patients (see 10 CLINICAL PHARMACOLOGY; Special Populations and Conditions).
Renal Impairment:
No dose adjustments are recommended for patients with mild or moderate renal impairment. Patients with > 1 g protein (24 h collection) at baseline were excluded from the pivotal clinical studies. pms-PAZOPANIB is not recommended for patients with severe renal impairment (see 10 CLINICAL PHARMACOLOGY; Special Populations and Conditions).
Coadministration with strong CYP3A4 inhibitor:
If coadministration of a strong CYP3A4 inhibitor with pms-PAZOPANIB cannot be avoided, reduce the dose of pms-PAZOPANIB to 400 mg. Further dose reductions may be needed if adverse effects occur during therapy. 4 Drug-Drug Interactions - CYP3A4 Inhibitors).
Geriatrics:
No alteration of dosage, dosing frequency or route of administration is required in patients over 65 years. 2 Recommended Dose and Dosage Adjustment The recommended dose of pms-PAZOPANIB for the treatment of mRCC and STS is 800 mg orally once daily.
3 Pharmacokinetics). 4 Administration For oral use. 3 Pharmacokinetics). 5 Missed Dose If a dose is missed, pms-PAZOPANIB should not be taken if it is less than 12 hours until the next dose.
1 Adverse Reaction Overview The safety of pazopanib has been evaluated in more than 1600 patients in clinical trials including 977 patients in the monotherapy studies which include 586 mRCC patients. The mRCC data described below reflect exposure to pazopanib in 290 mRCC patients who participated in a randomized, double- blind, placebo-controlled study (VEG105192).
8 months for the placebo arm. Forty-two percent (42%) of patients on pazopanib required a dose interruption and thirty-six percent (36%) required a dose reduction. The safety and efficacy of pazopanib in soft tissue sarcoma (STS) were evaluated in a randomized, double-blind, placebo-controlled multi-centre study (VEG110727).
Patients (N = 369) with advanced STS who had received prior anthracycline treatment, or were unsuited for such therapy, were randomized to receive pazopanib 800 mg once daily (N = 246) or placebo (N = 123). 9 months for the placebo arm.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Potentially serious adverse reactions with pazopanib included hepatic effects, hypertension, QT prolongation and Torsade de Pointes, arterial and venous thrombotic events, cardiac dysfunction, hemorrhagic events and gastrointestinal perforation and fistula (see 7 WARNINGS AND PRECAUTIONS).
Other important serious adverse reactions identified in STS trials included venous thromboembolic events and pneumothorax. pms-PAZOPANIB – Product Monograph Page 18 of 54 Metastatic Renal Cell Carcinoma Table 2 presents the most common adverse reactions occurring in ≥ 10 % of patients who received pazopanib in the pivotal mRCC study.
and 14 CLINICAL TRIALS). Clinical effectiveness of pazopanib in STS is based on significant progression-free survival benefit in patients with advanced STS. Prolongation of overall survival was not demonstrated nor were quality-of-life differences shown between patients receiving pazopanib versus placebo in the pivotal phase III trial (see 14 CLINICAL TRIALS).
3 Pediatrics). Toxicology studies in rodents showed hypertrophy of epiphyseal growth plates and abnormalities in growing incisors and severe effects on body weight gain, organ growth and organ maturation during early post-natal development (see 16 NON-CLINICAL TOXICOLOGY).
pms-PAZOPANIB is not recommended for use in children and is contraindicated in children less than 2 years of age (see 2 CONTRAINDICATIONS). 2 Geriatrics Geriatrics (65 years of age and over): In clinical trials with pazopanib for the treatment of mRCC, 196 patients (33%) were aged ≥65 years, and 34 patients (6%) were aged >75 years.
In the STS clinical trials, 93 patients (24%) were aged ≥ 65 years, and 17 subjects (4%) were aged ≥75 years. No overall differences in safety or effectiveness of pazopanib were observed between these patients and younger patients in clinical trials.
However, a meta-analysis shows that patients over 60 years of age may be at greater risk for ALT >3 X ULN. Although no other differences in responses between elderly and younger patients have been identified clinically; a greater sensitivity of some older individuals cannot be ruled out.
2 CONTRAINDICATIONS pms-PAZOPANIB (pazopanib as pazopanib hydrochloride) is contraindicated for: Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING section of the product monograph. Pediatric patients less than 2 year of age. Pazopanib is an anti-angiogenic agent that severely affects body weight gain, organ growth and organ maturation during early post-natal development in rats (see 7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY).
). 2 Geriatrics Geriatrics (65 years of age and over): In clinical trials with pazopanib for the treatment of mRCC, 196 patients (33%) were aged ≥65 years, and 34 patients (6%) were aged >75 years. In the STS clinical trials, 93 patients (24%) were aged ≥ 65 years, and 17 subjects (4%) were aged ≥75 years.
No overall differences in safety or effectiveness of pazopanib were observed between these patients and younger patients in clinical trials. However, a meta-analysis shows that patients over 60 years of age may be at greater risk for ALT >3 X ULN.
Although no other differences in responses between elderly and younger patients have been identified clinically; a greater sensitivity of some older individuals cannot be ruled out. 2 CONTRAINDICATIONS pms-PAZOPANIB (pazopanib as pazopanib hydrochloride) is contraindicated for: Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING section of the product monograph. Pediatric patients less than 2 year of age. Pazopanib is an anti-angiogenic agent that severely affects body weight gain, organ growth and organ maturation during early post-natal development in rats (see 7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pazopanib in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Table 2 Adverse Reactions Occurring in ≥10 % of mRCC Patients who Received Pazopanib (Study VEG105192) Reactions Pazopanib (N = 290) Placebo (N = 145) All Grades* Grade 3 Grade 4 All Grades* Grade 3 Grade 4 % % % % % % Gastrointestinal disorders Diarrhea 52 3 <1 9 <1 0 Nausea 26 <1 0 9 0 0 Vomiting 21 2 <1 8 2 0 Abdominal pain 11 2 0 1 0 0 Vascular disorders Hypertension 40 4 0 10 <1 0 General disorders and administrative site conditions Fatigue 19 2 0 8 1 1 Asthenia 14 3 0 8 0 0 Skin and subcutaneous tissue disorders Hair colour changes 38 <1 0 3 0 0 Metabolism and nutrition disorders Anorexia 22 2 0 10 <1 0 Nervous system disorder Headache 10 0 0 5 0 0 * National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
pms-PAZOPANIB – Product Monograph Page 19 of 54 Soft Tissue Sarcoma Table 3 presents the most common adverse reactions occurring in ≥ 10 % of patients who received pazopanib in the pivotal STS study. Table 3 Adverse Reactions Occurring in ≥ 10% of patients with STS who Received Pazopanib (study VEG110727) Adverse Reactions Pazopanib Placebo (N = 240) (N = 123) All Gradesa Grade 3 Grade 4 All Gradesa Grade 3 Grade 4 % % % % % % Fatigue 65 13 <1 48 4 <1 Diarrhea 59 5 0 15 <1 0 Nausea 56 3 0 22 2 0 Weight decreased 48 4 0 15 0 0 Hypertension 42 7 0 6 0 0 Appetite decreased 40 6 0 19 0 0 Hair color changes 39 0 0 2 0 0 Vomiting 33 3 0 11 <1 0 Tumour pain 29 8 0 21 7 2 Dysgeusia 28 0 0 3 0 0 Headache 23 <1 0 8 0 0 Musculoskeletal pain 23 2 0 20 2 0 Myalgia 23 2 0 9 0 0 Gastrointestinal pain 23 3 0 9 4 0 Dyspnea 20 5 <1 17 5 <1 Exfoliative rash 18 <1 0 9 0 0 Cough 17 <1 0 12 <1 0 Peripheral edema 14 2 0 9 2 0 Alopecia 12 0 0 <1 0 0 Dizziness 11 <1 0 4 0 0 Skin disorderb 11 2 0 <1 0 0 Skin hypopigmentation 11 0 0 0 0 0 Stomatitis 11 <1 0 3 0 0 Chest pain 10 2 0 6 0 0 a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
b 27 of the 28 cases of skin disorder were palmar-plantar erythrodysesthesia. Metastatic Renal Cell Carcinoma and Soft Tissue Sarcoma Other adverse reactions observed more commonly in mRCC and STS patients treated with pazopanib with incidence more than 2% greater than placebo included: Bradycardia: Based on heart rate measurement (<60 beats per minute), asymptomatic bradycardia was observed in 12% (33/280) patients treated with pazopanib and in 8% (11/144) of patients on the placebo pms-PAZOPANIB – Product Monograph Page 20 of 54 arm in the randomized RCC trial.
In the randomized trial of pazopanib for the treatment of STS, asymptomatic bradycardia was observed in 10% (24/238) of patients treated with pazopanib and in 2% (2/121) patients on the placebo arm. 1%) based on a review of the pazopanib clinical trials safety database.
Diarrhea:
Diarrhea occurred frequently and was predominantly mild to moderate in severity in both the RCC and STS clinical trials. Patients should be advised how to manage mild diarrhea and instructed to notify their healthcare provider if moderate to severe diarrhea occurs so appropriate management can be implemented to minimize this impact.
Amylase/Lipase Elevations:
In a single-arm mRCC phase II clinical study, increases in amylase values were observed for 42/184 patients (23%) and increases in lipase values were observed for 48/181 patients (27%). Increased blood amylase as an adverse reaction was reported for 6/225 patients (3%), all were Grade 1 or Grade 2 in severity.
Elevations in lipase as an adverse reaction were reported for 10 patients (4%) and were Grade 3 for 6 patients and Grade 4 for 1 patient. 7%).
Pneumothorax:
Two of 290 patients treated with pazopanib in the mRCC trial developed a […]
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions pms-PAZOPANIB tablets should be prescribed by a physician experienced in the administration of anti-cancer agents. Monitor hepatic function (see Monitoring and Laboratory Tests section) and interrupt, reduce or discontinue dosing as recommended (see Hepatic section).
5 X ULN (with direct bilirubin >35%) and ALT elevations of >2 X ULN, or who have moderate or severe hepatic impairment (Child Pugh B and C). Patients over 60 years of age may be at greater risk for ALT >3 X ULN. See Hepatic section and 4 DOSAGE AND ADMINISTRATION, Hepatic Impairment.
1 Dosing Considerations Dose modification, either an increase or decrease in dose, should be in 200 mg increments in a stepwise fashion based on individual tolerability in order to manage adverse reactions. The dose of pms-PAZOPANIB should not exceed 800 mg.
5 X ULN (with direct bilirubin >35%) and ALT elevations >2 X ULN, or who have moderate or severe hepatic impairment (Child-Pugh B and C). No formal studies have been carried out in patients with mild hepatic impairment and caution is recommended in these patients (see 10 CLINICAL PHARMACOLOGY; Special Populations and Conditions).
Renal Impairment:
No dose adjustments are recommended for patients with mild or moderate renal impairment. Patients with > 1 g protein (24 h collection) at baseline were excluded from the pivotal clinical studies. pms-PAZOPANIB is not recommended for patients with severe renal impairment (see 10 CLINICAL PHARMACOLOGY; Special Populations and Conditions).
Coadministration with strong CYP3A4 inhibitor:
If coadministration of a strong CYP3A4 inhibitor with pms-PAZOPANIB cannot be avoided, reduce the dose of pms-PAZOPANIB to 400 mg. Further dose reductions may be needed if adverse effects occur during therapy. 4 Drug-Drug Interactions - CYP3A4 Inhibitors).
Geriatrics:
No alteration of dosage, dosing frequency or route of administration is required in patients over 65 years. 2 Recommended Dose and Dosage Adjustment The recommended dose of pms-PAZOPANIB for the treatment of mRCC and STS is 800 mg orally once daily.
3 Pharmacokinetics). 4 Administration For oral use. 3 Pharmacokinetics). […]