Phesgo IV Infusion

Phesgo IV Infusion is used for: Early Breast Cancer, Metastatic Breast Cancer

Early Breast Cancer Neoadjuvant treatment Indicated in combination with chemotherapy for neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either >2 cm in diameter or node positive as part of a complete treatment regimen for early breast cancer [EBC]) Treated with IV pertuzumab and trastuzumab within 6 weeks: 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC initially and then q3Weeks for subsequent administrations Treated with IV pertuzumab and trastuzumab >6 weeks: 1,200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase SC initially followed by 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC q3Weeks for subsequent administrations Administer for 3-6 cycles as part of a treatment regimen for EBC Following surgery Continue to receive pertuzumab/trastuzumab/hyaluronidase to complete 1 year of treatment (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs first Adjuvant treatment Indicated in combination with chemotherapy for adjuvant treatment of adults with HER2-positive EBC at high risk of recurrence Treated with IV pertuzumab and trastuzumab within 6 weeks: 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC initially and then q3Weeks for subsequent administrations Treated with IV pertuzumab and trastuzumab ?6 weeks: 1,200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase SC initially followed by 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC q3Weeks for subsequent administrations Administer for a total of 1 year (up to 18 cycles) or until disease recurrence or unmanageable toxicity, whichever occurs first For taxane-based regimens: Start on Day 1 Metastatic Breast Cancer Indicated in combination with docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease Treated with IV pertuzumab and trastuzumab within 6 weeks: 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC initially and then q3Weeks for subsequent administrations Treated with IV pertuzumab and trastuzumab >6 weeks: 1,200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase SC initially followed by 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase SC q3Weeks for subsequent administrations When administered with Pertuzumab + Trastuzumab + Hyaluronidase, start with docetaxel is 75 mg/m2 IV initially; may escalate dose to 100 mg/m2 IV q3Weeks if initial dose is well tolerated Continue until disease progression or unmanageable toxicity, whichever occurs first

Renal impairment All severities: No clinically significant differences in the pharmacokinetics of pertuzumab and trastuzumab were observed

Contraindicated (0) Serious (3) beclomethasone, inhaled etrasimod palifermin

Side effects of Pertuzumab + Trastuzumab + Hyaluronidase : >50% All grades Low hemoglobin (90%) Low absolute lymphocytes (89%) High creatinine (84%) Low total leukocytes (82%) Alopecia (77%) Low total absolute neutrophils (68%) Nausea (60%) Diarrhea (17-60%) High ALT (58%) >10-50% All grades High AST (50%) Anemia (36%) Asthenia (11-31%) Fatigue (29%) Low platelets (27%) Stomatitis (25%) Myalgia (25%) Arthralgia (19-24%) Constipation (22%) Neutropenia (22%) Vomiting (20%) Radiation skin injury (19-20%) Decreased appetite (17%) Dysgeusia (17%) Headache (17%) Insomnia (17%) Low potassium (17%) Low albumin (16%) Peripheral sensory neuropathy (16%) Rash (16%) Mucosal inflammation (15%) Dry skin (15%) Cough (15%) Injection site reaction (13-15%) Dyspepsia (12-14%) Pyrexia (13%) Dizziness (13%) Procedural pain (13%) High potassium (13%) Low sodium (13%) Epistaxis (12%) Peripheral neuropathy (12%) Hot flush (11-12%) Decreased weight (11%) Upper respiratory tract infection (11%) Grade 3 or 4 Low absolute lymphocytes (37%) Low total absolute neutrophils (30%) Low total leukocytes (25%) Neutropenia (14%) 1-10% All grades Paresthesia (10%) Back pain (10%) Pruritus (10%) High bilirubin (9%) Low glucose (9%) Nail discoloration (9%) Erythema (9%) Hemorrhoids (9%) Abdominal pain (9%) Leukopenia (9%) Upper abdominal pain (8%) Peripheral edema (8%) High sodium (7%) Malaise (7%) Febrile neutropenia (7%) Dermatitis (7%) Nail disorder (7%) Bone pain (7%) Pain in extremity (6%) Muscle spasms (6%) Musculoskeletal pain (6%) Palmoplantar erythrodysesthesia syndrome (6%) Influenza-like illness (5%) Heart failure (1.2%) Hypersensitivity (1.2%) Grade 3 or 4 Febrile neutropenia (7%) Diarrhea (7%) Low potassium (5.2%) Low hemoglobin (2.8%) Leukopenia (2.4%) Fatigue (2%) Nausea (2%) Anemia (1.6%) High ALT (1.6%) Hypokalemia (1.6%) High potassium (1.2%) Dyspnea (1.2%) <1% Grade 3 or 4 High sodium (0.8%) Mucosal inflammation (0.8%) High AST (0.8%) Decreased appetite (0.8%) Decreased weight (0.8%) Paresthesia (0.8%) Peripheral sensory neuropathy (0.8%) Vomiting (0.8%) Stomatitis (0.8%) Palmoplantar erythrodysesthesia syndrome (0.8%) Heart failure (0.8%) Asthenia (0.4%) Abdominal pain (0.4%) Peripheral neuropathy (0.4%) Low sodium (0.4%) Lacrimation increased (0.4%) Dry eye (0.4%) Radiation skin injury (0.4%) Paronychia (0.4%) Urinary tract infection (0.4%) Cough (0.4%) Musculoskeletal pain (0.4%) Myalgia (0.4%) Dry skin (0.4%) Rash (0.4%)

Phesgo (600 mg+600 mg)/vial IV Infusion manufactured by Roche Bangladesh Limited. Its generic name is Pertuzumab + Trastuzumab + Hyaluronidase. Phesgo is availble in Bangladesh. Farmaco BD drug index information on Phesgo IV Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.