Prostate Cancer Drug Summary

• GI effects (nausea/vomiting, diarrhea, elevated liver function tests [LFTs], hepatitis); Other effects (pruritus, testosterone and adrenal steroid synthesis inhibition, gynecomastia, allergic reactions)

• Use with caution in patients with adrenal insufficiency
• Contraindicated in patients with liver disease, in recovery phase of hepatitis, and hepatic impairment
• Monitor LFTs during treatment

• Musculoskeletal effects (falls, fractures, arthralgia); CV effects (QT prolongation, ischemic heart disease, heart failure); Metabolic effects (hypercholesterolemia, hypertriglyceridemia, hyperkalemia, hyperglycemia); GI effects (diarrhea, nausea); Dermatologic effects (rash, pruritus); Hematologic effects (anemia, leukopenia, lymphopenia); Other effects (fatigue, peripheral edema, decreased weight)

• Use with caution in patients with history of seizures or predisposing factors for seizure, risk of falls or fractures, recent CV disease and QT prolongation, severe renal or hepatic impairment

Adverse Reactions

• Dermatologic effects (pruritus, alopecia, hair regrowth, dry skin); GI effects (nausea, diarrhea, hepatic changes); Other effects (gynecomastia, breast tenderness/pain, weight gain, decreased libido, impotence, asthenia, anemia, hot flushes)

Special Instructions

• When used for the treatment of locally advanced PC at high risk for disease progression, therapy should be taken continuously for at least 2 years or until disease progression
• Use with caution in patients with moderate to severe hepatic impairment, hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

Adverse Reactions

• GU effect (inhibition of spermatogenesis); Other effects (tiredness, diminished vitality, depressive mood, restlessness, weight change, breast tension, gynecomastia)
• With high doses: Liver function disturbances, shortness of breath sensation, reduced adrenal cortex function

Special Instructions

• Should be taken with food
• Use with caution in patients with sickle cell anemia, severe diabetes with vascular changes or history of thromboembolic processes, liver function impairment; regular liver function, adrenocortical function and RBC count monitoring is advised
• Should not be given before the conclusion of puberty
• Contraindicated in patients with liver diseases or existing liver tumors, history of jaundice, Dubin-Johnson syndrome, Rotor syndrome, severe chronic depression, previous or existing thromboembolic processes, severe diabetes with vascular changes, sickle-cell anemia

Adverse Reactions

• CV effects (ischemic heart disease, heart failure); Other effects (fatigue, asthenia, pain in extremity, rash, decreased neutrophil count, increased AST, increased bilirubin)

Special Instructions

• Swallow tablets whole with food
• Use with caution in patients with severe renal impairment, moderate hepatic impairment, significant CV disease
• Contraception is advised during and for 1 week after treatment

• CNS effects (headache, memory impairment, cognitive disorder, anxiety); Dermatologic effects (pruritus, dryness); Other effects (hot flushes, visual hallucinations, fractures, hypertension, fatigue)

• Use with caution in patients with history of seizures, renal and hepatic impairment, recent CV disease, fructose intolerance, and for those undergoing anticoagulant treatment
• Contraception is advised during and for 3 months after treatment

Adverse Reactions

• GI effects (nausea/vomiting, diarrhea, increased appetite, transient abnormal liver function); Neurologic effect (insomnia); GU effects (reduced sperm count, decreased libido, impotence); Other effects (gynecomastia, breast tenderness, galactorrhea, tiredness, chest pain, hair growth changes)

Special Instructions

• Use with caution in patients with liver injury or jaundice, serum transaminase >2-3x upper limit of normal (ULN); perform periodic LFTs

• CNS effects (headache, memory impairment, cognitive disorder, anxiety); Dermatologic effects (pruritus, dryness); Other effects (hot flushes, visual hallucinations, fractures, hypertension)

• Use with caution in patients with anti-androgen withdrawal syndrome, QT prolongation history, risk for torsades de pointes, Japanese ethnicity
• Monitor hepatic and pulmonary function prior to and during treatment
• Contraindicated in patients with severe hepatic impairment, respiratory insufficiency, and those with treatment failure with previous hormonal treatment

Adverse Reactions

• Neurologic effects (depressive moods, dizziness, headache); GI effects (nausea/vomiting, diarrhea); GU effect (obstructed micturition); Dermatologic effect (skin reddening); Respiratory effects (thrombosis with pulmonary embolism, dyspnea); Musculoskeletal effects (bone pain, weakness); Other effects (loss of libido, breast enlargement, hot flushes, urticaria)

Special Instructions

• Contraindicated in patients who recently underwent orchiectomy
• Use with caution in patients with hypertension, diabetes, depression and those with increased risk of osteoporosis

• Musculoskeletal effects (arthralgia, paresthesias, increase in bone pain, decreased bone mineral density); GU effect (ureteric obstruction); Dermatologic effects (rashes, burning at injection site, sweating); CV effect (BP changes); Other effects (hot flushes, decreased libido, breast swelling/tenderness)

• Use with caution in patients with increased risk for urinary obstruction and spinal cord compression, pre-existing DM, reduced glucose tolerance during LHRH treatment

• CNS effects (insomnia, decreased libido, headache); GI effect (constipation); GU effects (hematuria, urethral/bladder outlet obstruction, transient increase in serum testosterone, erectile dysfunction, testicular atrophy, renal impairment); Dermatologic effect (implant site reaction); Musculoskeletal effect (decreased bone density); Other effects (hot flushes, fatigue, increased weight, gynecomastia)

• Insert implant in the inner aspect of the upper arm
• Contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or synthetic LHRH or LHRH agonist analog
• Use with caution in patients with metastatic vertebral lesions and/or urinary tract obstruction
• Avoid wetting inserted arm 24 hours after implantation, and heavy lifting or strenuous exertion using the implanted arm for 7 days

• GI effects (nausea/vomiting); Musculoskeletal effects (transient increase in bone pain, weakness/paresthesia of the lower limbs); GU effects (worsening of preexisting hematuria or urinary obstruction, impotence, testicular atrophy); CNS effects (headache, insomnia, dizziness, diaphoresis); Other effects (hot flushes, limb edema, erythema, fatigue, injection site burning, decrease in libido, gynecomastia)

• Use with caution in patients with urinary obstruction and/or metastatic vertebral lesions
• Follow the correct preparation and administration steps to avoid medication errors
• Should only be administered by a trained healthcare professional
• Monitor testosterone and PSA levels

• Musculoskeletal effects (paresthesia in lower limbs, back pain, musculoskeletal pain, pain in extremity); Dermatologic effects (inflammation, edema, injection site reaction, erythema); CNS effects (headache, dizziness); Other effects (loss of libido, hot flushes, hyperhidrosis, erectile dysfunction, fatigue, urinary symptoms, nausea)

• Use with caution in patients with additional risk factors for osteoporosis, known depression, high risk for metabolic or CV disease, and in patients currently on anticoagulant treatment
• Close monitoring is advised if Triptorelin is given in combination with drugs that modify the secretion of pituitary gonadotropins

Adverse Reactions

• CV effect (hypertension); Metabolic effects (hypokalemia, hypertriglyceridemia, increased ALT); GU effect (UTI); GI effects (diarrhea, vomiting); Other effects (peripheral edema, fluid retention, headache, upper respiratory tract infection, arthralgia)

Special Instructions

• Should be taken on an empty stomach
• Use with caution in patients with hypertension, hypokalemia and fluid retention (eg heart failure) due to excess mineralocorticoid, hepatotoxicity, corticosteroid withdrawal in stressful situations
• Contraindicated in patients with severe hepatic impairment
• Monitor blood pressure, liver function and serum potassium

Adverse Reactions

• GI effects (diarrhea, nausea, increased liver transaminases); CNS effects (dizziness, insomnia, headache); GU effects (testicular atrophy, erectile dysfunction); Dermatologic effects (injection site reaction, rash, hyperhidrosis); Other effects (hot flushes, anemia, increased weight, musculoskeletal pain, chills, pyrexia, fatigue, flu-like illness)

Special Instructions

• Use with caution in patients with history of corrected QT interval >450 millisec, torsades de pointes, severe untreated asthma, anaphylactic reactions/urticaria/angioedema, decreased bone density, glucose tolerance, renal and hepatic impairment

• GI effects (constipation, diarrhea); Metabolic effects (increased glucose, increased triglycerides, increased AST, increased ALT); Other effects (hot flush, musculoskeletal pain, decreased Hb)

• Use with caution in patients taking P-gp inhibitors and strong CYP3 inducers

• GI effects (nausea/vomiting, diarrhea); Dermatologic effects (hypersensitivity reactions, skin rash, urticaria); Metabolic effect (hyperglycemia); CV effects (thromboembolic phenomena, fluid retention/edema); Other effects (tumor flare, dyspnea, weight gain, carpal tunnel syndrome, alopecia)

• Should be taken with food
• Use with caution in patients with history of thrombophlebitis

Adverse Reactions

• GI effects (nausea/vomiting, diarrhea); CV effects (CHF, ventricular tachycardia, AV block, bundle branch block, bradycardia, thromboembolism, asymptomatic drops in left ventricular ejection fraction [LVEF]); Hematologic effects (secondary leukemia, acute lymphocytic and myelogenous leukemia, leukopenia, neutropenia, anemia, thrombocytopenia); CNS effect (anorexia); Other effects (infections, conjunctivitis, keratitis, pneumonia, hyperuricemia, chemical cystitis, embolism, injection site reaction)

Special Instructions

• Contraindicated in patients with persistent myelosuppression, severe hepatic impairment, cardiomyopathy, recent MI, severe arrhythmias, previous treatments with Epirubicin at maximum dose and/or other anthracyclines and anthracenediones
• Use with caution in patients with hepatic impairment, phlebosclerosis, tumor lysis syndrome, catheterization problems, acute toxicities, generalized infections
• Monitor CBC, cardiac, hepatic and renal function
• Total cumulative dose for Doxorubicin should be <550 mg/m² (perform baseline echocardiogram) and Epirubicin 900-1,000 mg/m²

• GI effects (nausea/vomiting, stomatitis, diarrhea, abdominal pain, constipation, anorexia, mucositis, altered taste); CV effects (asymptomatic decrease in LVEF, transient ECG changes, arrhythmia); Respiratory effect (rhinitis); Musculoskeletal effect (cramps); CNS effects (somnolence, confusion, anxiety, mild paresthesia); Hematologic effects (transient leukopenia, thrombocytopenia, anemia); Ophthalmologic effects (reversible blue scleral discoloration, conjunctivitis); Other effects (neuritis, alopecia, urine discoloration, blue green nail/skin discoloration)

• Contraindicated in patients with severe bone marrow suppression
• Use with caution in patients with history of anthracycline treatment, myelosuppression, cardiac pathologies such as cardiac insufficiency and decreased LVEF, severe hepatic insufficiency, edema, ascites, pleural effusion
• Administration of live vaccines should be avoided

Adverse Reactions

• GI effects (nausea/vomiting, diarrhea, impaired liver function); CV effects (thromboembolism, ischemic heart disease, CHF, hypertension, MI); Other effects (fluid retention, edema, skin rashes, gynecomastia, impotence)

Special Instructions

• Discontinue if no effect is seen after 4-6 weeks
• Should be taken on an empty stomach, at least 1 hour before or 2 hours after meals; not to be taken with milk, milk products, or drugs containing calcium, magnesium or aluminum (eg antacids)
• Contraindicated in patients with severe liver disease, severe cardiovascular disease (ischemic, thromboembolic, or complications related to fluid retention
• Use with caution in patients with history of thrombophlebitis, thrombosis/thromboembolic disorders; cerebral vascular/CAD, diabetes, hypertension, exacerbation of preexisting or incipient peripheral edema, CHD, epilepsy, migraine, metabolic bone diseases, renal & hepatic insufficiency, patients at risk of hypercalcemia
• Administration of live or live-attenuated vaccines should be avoided

Adverse Reactions

• GU effects (mild reversible renal function impairment, microhematuria); Hematologic effects (leukopenia, thrombocytopenia, anemia, severe bone marrow depression); Other effects (GI and auditory disturbances, hyperuricemia, immunosuppression, peripheral neuropathy with paresthesia)
• Side-effects are dose-dependent

Special Instructions

• Contraindicated in patients with bone marrow depression, severe renal impairment, dehydration, chickenpox, herpes zoster, gout, urate calculi, recent infections, and Cisplatin-induced peripheral neuropathy
• Use with caution in patients with mild, renal, hematopoietic system and hearing impairment
• Monitoring of renal function, blood count, auditory function, liver enzymes and plasma and electrolytes prior to and during treatment are advised

Adverse Reactions

• GI effects (diarrhea, nausea/vomiting, constipation, abdominal pain, anorexia, dysgeusia); Hematologic effects (leukopenia, thrombocytopenia, anemia, neutropenia, febrile neutropenia); Respiratory effects (dyspnea, cough); Other effects (pyrexia, fatigue, hematuria, back pain, arthralgia)

Special Instructions

• Contraindicated in patients with neutrophil count <1,500/mm³, hepatic impairment, and concomitant vaccination with yellow fever vaccine
• Use with caution in patients with Hb <10 g/dL, risk of neutropenia, nausea, vomiting, diarrhea, dehydration, renal failure, cardiac arrhythmias, liver disease, epilepsy, and those currently on CYP3A4 inhibitors/inducers
• Monitor for hypersensitivity reactions and peripheral neuropathy

• GI effects (diarrhea, dysgeusia, stomatitis, nausea); Hematologic effects (febrile neutropenia, anemia); CNS effects (peripheral sensory neuropathy, anorexia); Dermatologic effects (rash, eruptions, alopecia, nail disorders); Other effects (infections, myalgia, fluid retention, asthenia, bone marrow suppression, hypotension, infusion site reaction, increased serum transaminases)

• Contraindicated in patients with baseline neutrophil count of <1,500 cell/mm³, severe liver impairment
• Use with caution in patients with neutropenia, fluid retention, liver/renal impairment, peripheral neurotoxicity, skin reactions

• Hematologic effects (anemia, decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets); GI effects (dry mouth, nausea, constipation); Other effects (decreased appetite, fatigue, decreased calcium, decreased sodium)

• Advise patient to increase oral fluid intake and to void as often as possible to reduce bladder radiation
• Avoid in patients with kidney failure with CrCl <30 mL/min, severe heart failure, impaired hematologic function, liver impairment
• Monitor CBC, kidney function

• GI effects (nausea/vomiting, diarrhea); Hematologic effects (thrombocytopenia, neutropenia, pancytopenia, leukopenia); Other effect (injection site reactions)

• Use with caution in patients with bone marrow suppression, Crohn’s disease and ulcerative colitis, acute inflammatory bowel disease, increased cancer risk, hereditary defects
• Obtain baseline hematologic values and orthopedic stabilization in patients at risk for fracture prior to every dose
• Advise patient to use effective contraceptive methods during and up to 6 months after treatment

• Hematologic effects (thrombocytopenia, leukopenia); Other effects (hot flushes, transient increased pain 36-72 hours post-injection)

• Use with caution in patients with previous extensive bone radiation, other bone seeking isotope injection, X-ray, chemotherapy; compromised bone marrow function; renal impairment, short life expectancy, local beam therapy
• Monitor CBCs (especially platelets) pre- and ≥8 weeks post-treatment
• Contraindicated in patients with severely compromised bone marrow unless benefit outweighs the risk
• Should not be administered rapidly (<30 seconds)
• Repeat administrations should not be performed within 3 months of the previous injection

• GI effects (abdominal pain, diarrhea, dyspepsia, flatulence, nausea); CNS effects (headache, dizziness, insomnia, depression); Respiratory effects (increased cough, pharyngitis, rhinitis, sinusitis, infection); Musculoskeletal effects (arthralgia, back pain, leg cramps, myalgia); Other effects (asthenia, flu syndrome, breast pain, pruritus)

• Should be taken with food to reduce nausea
• Use with caution in patients with hypertension, impaired hepatic function, hypertriglyceridemia, cholestatic jaundice, hypothyroidism, fluid retention, epilepsy, migraine, DM, porphyria, hypoparathyroidism, asthma, SLE and hepatic hemangiomas
• Contraindicated in patients with history of, known or suspected breast cancer; in patients with hepatocellular cancer, stroke, thromboembolic disease

• GI effect (GI disturbances); CNS effect; CV effect; Ophthalmologic effects (keratoconus, contact lenses intolerance); Other effects (jaundice, impotence, feminization, gynecomastia, hypercalcemia, chloasma, altered carbohydrate metabolism, loss of diabetic control)

• Use with caution in patients with renal and hepatic impairment
• Contraindicated in patients with thromboembolic disease and porphyria

• GI effects (changes in appetite, GI disturbances, liver enzyme changes); Dermatologic effects (chloasma, rashes, acne, hair loss, hirsutism); CNS effects (drowsiness, insomnia, headache, mental depression); Other effects (fever, breast changes, fluid retention, fatigue, changes in libido, jaundice, changes in serum lipid profile)

• Should be taken with food
• Use with caution in patients with CV or renal impairment, DM, asthma, epilepsy, migraine, depression and other conditions aggravated by fluid retention
• Contraindicated in patients with thrombophlebitis, thromboembolic disturbances, hepatic insufficiency, hormone-dependent carcinoma

• GI effects (nausea, constipation, decreased appetite, diarrhea); Respiratory effects (cough, pneumonitis, dyspnea, pneumonia); Dermatologic effects (pruritus, rash, cellulitis); Other effects (fatigue, arthralgia, renal failure, pain)

• Withhold treatment if any of the following occurs: Moderate pneumonitis, moderate or severe immune-mediated colitis, moderate hypophysitis, severe hyperglycemia, moderate immune-mediated nephritis
• Discontinue if life-threatening adverse events of pneumonitis, colitis, hypophysitis, hyperthyroidism, nephritis, infusion reactions, severe liver enzyme elevations occur
• Monitor liver enzymes, serum creatinine, and thyroid and renal function

Adverse Reactions

• GI effects (dysgeusia, nausea/vomiting, diarrhea, dyspepsia, stomatitis, upper abdominal pain); Hematologic effects (anemia, neutropenia, lymphopenia, mean corpuscular volume elevation, thrombocytopenia); CNS effects (headache, dizziness); Other effects (increased creatinine, decreased appetite, fatigue)

Special Instructions

• Should be taken on an empty stomach
• Start treatment not later than 8 weeks after completion of final dose of the platinum-containing regimen
• Interrupt treatment if severe hematological toxicity or blood transfusion dependence develops, or if new or worsening respiratory symptoms or a radiological abnormality occurs; discontinue treatment if pneumonitis is confirmed
• Use with caution in patients with myelodysplastic syndrome/acute myeloid leukemia, moderate to severe renal impairment, hepatic impairment
• Avoid co-administration with strong CYP3A inducers or inhibitors

Adverse Reactions

• GI effects (nausea/vomiting, constipation, abdominal pain); Respiratory effects (acute respiratory distress syndrome, pneumonia); CV effects (QT prolongation, cardiac failure); Hematologic effects (anemia, thrombocytopenia, leukopenia, neutropenia); Metabolic effect (dyslipidemia, increased serum creatinine, increased ALT, AST and alkaline phosphatase); Other effects (rash, asthenia, fatigue, balance disorder, decreased appetite, decreased weight)

Special Instructions

• Contraindicated in patients with leukemia, myelodysplastic syndrome
• Monitor CBC

Adverse Reactions

• Hematologic effects (anemia, lymphopenia, neutropenia, leukopenia, thrombocytopenia); Metabolic effects (increased glucose, increased AST, ALT, alkaline phosphatase, decreased calcium, sodium, phosphate, magnesium); CNS effects (headache, dizziness); GI effects (nausea/vomiting, diarrhea, dysgeusia); Other effects (fatigue, decreased appetite, fractures)

Special Instructions

• Use with caution in patients with moderate to severe renal impairment, myelodysplastic syndrome/acute myeloid leukemia, myelosuppression
• Patients should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy

• Dermatologic effects (alopecia, hyperhidrosis); Musculoskeletal effects (musculoskeletal pain, osteonecrosis of the jaw); Metabolic effects (hypocalcemia, hypophosphatemia); Other effects (dyspnea, diarrhea, new primary malignancy, tooth extraction)

• Hypocalcemia should be corrected prior to initiating therapy
• Contraindicated in patients with hypocalcemia

• CV effects (hypotension, hypertension, bradycardia, atrial fibrillation, peripheral edema, chest pain); CNS effects (insomnia, somnolence, anxiety, depression, confusion, agitation, headache, dizziness, vertigo, asthenia, paresthesia, taste disturbance, hypoesthesia, hyperesthesia, tremor, hallucination); GI effects (abdominal pain, nausea/vomiting, anorexia, dyspepsia, constipation, diarrhea, stomatitis, sore throat, decreased/increased weight, dehydration, decreased appetite, dry mouth); Hematologic effects (anemia, neutropenia, granulocytopenia, thrombocytopenia, leukopenia, pancytopenia); Musculoskeletal effects (myalgia, bone pain, back pain, arthralgia, muscle cramps); Metabolic effects (hypophosphatemia, hypomagnesemia, hyperkalemia, hypokalemia, hypernatremia, increased creatinine, hypocalcemia); Ophthalmologic effects (uveitis, conjunctivitis); Other effects (fever and flu-like syndrome, progression of cancer, fatigue, chills, weakness)

• Use with caution in patients with renal and hepatic impairment, asthma
• Evaluate serum creatinine concentration prior to therapy
• Monitor serum levels of Ca, phosphate and Mg after initiating therapy; hydration and electrolyte levels
• Discontinue use if ocular disturbances occur