Fortovase Side Effects

Please note - some side effects for Fortovase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Fortovase - for the Consumer

Fortovase

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fortovase:

Anxiety; blurred vision; bronchitis; change in sexual ability; constipation; diarrhea; dry lips/skin; gas; headache; heartburn; loss of appetite; nausea; night sweats; sleeplessness; stomach discomfort; taste change; tiredness; vomiting; warts; weight gain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; bloody stools; body fat changes; chest pain; confusion; coughing up blood; dark urine; difficulty urinating; dizziness; excessive thirst, hunger, or urination; fast heartbeat; fever; flu-like symptoms; fruity breath odor; itching; loss of coordination; mental or mood changes; muscle pain; numbness or tingling; pneumonia; seizures; shortness of breath; slow onset of drowsiness; stomach pain or tenderness; tenderness or bleeding of gums; thoughts of hurting yourself; unusual vaginal discharge or odor; unusual weakness; white patches in mouth; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Fortovase Side Effects - for the Professional

Fortovase

The safety of Fortovase was studied in more than 500 patients who received the drug either alone or in combination with other antiretroviral agents. The majority of treatment-related adverse events were of mild intensity. The most frequently reported treatment-emergent adverse events among patients receiving Fortovase in combination with other antiretroviral agents were diarrhea, nausea, abdominal discomfort, and dyspepsia.

Clinical adverse events of at least moderate intensity, which occurred in ≥2% of patients in studies NV15182 (an open-label, single-arm safety study) and NV15355 (an open-label randomized study comparing Fortovase and INVIRASE) are summarized in Table 7. The median duration of treatment in studies NV15182 and NV15355 were 52 and 18 weeks, respectively. In NV15182, more than 300 patients were on treatment for approximately 1 year.

Fortovase did not appear to alter the pattern, frequency or severity of known major toxicities associated with the use of nucleoside analogues. Physicians should refer to the complete product information for other antiretroviral agents as appropriate for drug-associated adverse reactions to these other agents.

Rare occurrences of the following serious adverse experiences have been reported during clinical trials of Fortovase and/or INVIRASE and were considered at least possibly related to use of study drugs: confusion, ataxia and weakness; seizures; headache; acute myeloblastic leukemia; hemolytic anemia; thrombocytopenia; thrombocytopenia and intracranial hemorrhage leading to death; attempted suicide; Stevens-Johnson syndrome; bullous skin eruption and polyarthritis; severe cutaneous reaction associated with increased liver function tests; isolated elevation of transaminases; exacerbation of chronic liver disease with Grade 4 elevated liver function tests, jaundice, ascites, and right and left upper quadrant abdominal pain; pancreatitis leading to death; intestinal obstruction; portal hypertension; thrombophlebitis; peripheral vasoconstriction; drug fever; nephrolithiasis; and acute renal insufficiency.

Concomitant Therapy with Ritonavir

Includes events with unknown relationship to study drug.

Laboratory Abnormalities

In the MaxCmin 1 study, Grade 3 and 4 thrombocytopenia (2.0% of patients) and anemia (2.0%) were observed with Fortovase in combination with ritonavir. At 48 weeks, other lab abnormalities included increased ALT, increased AST, increased GGT, hyperglycemia, hypertriglyceridemia, increased TSH, neutropenia, raised amylase, and increased LDH.

Table 9 summarizes the percentage of patients with marked laboratory abnormalities in study NV15182 and NV15355 (median duration of treatment was 52 and 18 weeks, respectively). In study NV15182, by 48 weeks <1% of patients discontinued treatment due to laboratory abnormalities.

In the safety study (NV15182), 27% to 33% of subjects experienced ≥1 grade shifts in ALT and AST during the 48-week study period. In 46% of such events, there was a single abnormal transaminase level with no evidence of persistently elevated enzyme values during the course of study. Only 3% to 4% of patients had ≥3 grade shifts in transaminase levels and less than 0.5% of patients had to discontinue the study for increased liver function test values.

Additional marked lab abnormalities have been observed with INVIRASE. These include: calcium (low), phosphate (low), potassium (low), sodium (low).

Monotherapy and Combination Studies

Other clinical adverse experiences of any intensity, at least remotely related to Fortovase and INVIRASE, including those in <2% of patients, are listed below by body system.

Mouth dry, night sweats, sweating increased

Allergic reaction, anorexia, appetite decreased, appetite disturbances, asthenia, chest pain, edema, fever, intoxication, malaise, olfactory disorder, pain body, pain pelvic, retrosternal pain, shivering, trauma, wasting syndrome, weakness generalized, weight decrease, redistribution/accumulation of body fat

Cyanosis, heart murmur, heart rate disorder, heart valve disorder, hypertension, hypotension, stroke, syncope, vein distended

Ataxia, cerebral hemorrhage, confusion, convulsions, dizziness, dysarthria, dysesthesia, hyperesthesia, hyperreflexia, hyporeflexia, light-headed feeling, myelopolyradiculoneuritis, neuropathy, numbness extremities, numbness face, paresis, paresthesis, peripheral neuropathy, poliomyelitis, prickly sensation, progressive multifocal leukoencephalopathy, spasms, tremor, unconsciousness

Acne, alopecia, chalazion, dermatitis, dermatitis seborrheic, erythema, folliculitis, furunculosis, hair changes, hot flushes, nail disorder, papillomatosis, papular rash, photosensitivity reaction, pigment changes skin, parasites external, pruritus, psoriasis, rash maculopapular, rash pruritic, red face, skin disorder, skin nodule, skin syndrome, skin ulceration, urticaria, verruca, xeroderma

Dehydration, diabetes mellitus, hyperglycemia, hypoglycemia, hypothyroidism, thirst, triglyceride increase, weight increase

Abdominal distention, bowel movements frequent, buccal mucosa ulceration, canker sores oral, cheilitis, colic abdominal, dysphagia, esophageal ulceration, esophagitis, eructation, fecal incontinence, feces bloodstained, feces discolored, gastralgia, gastritis, gastroesophageal reflux, gastrointestinal inflammation, gingivitis, glossitis, hemorrhage rectum, hemorrhoids, infectious diarrhea, melena, painful defecation, parotid disorder, pruritus ani, pyrosis, salivary glands disorder, stomach upset, stomatitis, taste unpleasant, toothache, tooth disorder, ulcer gastrointestinal

Anemia, neutropenia, pancytopenia, splenomegaly

Cholangitis sclerosing, cholelithiasis, hepatitis, hepatomegaly, hepatosplenomegaly, jaundice, liver enzyme disorder, pancreatitis

Arthralgia, arthritis, back pain, cramps leg, cramps muscle, lumbago, musculoskeletal disorders, myalgia, myopathy, pain facial, pain jaw, pain leg, pain musculoskeletal, stiffness, tissue changes

Kaposi's sarcoma, tumor

Bleeding dermal, hemorrhage, microhemorrhages, thrombocytopenia

Agitation, amnesia, anxiety attack, behavior disturbances, dreaming excessive, euphoria, hallucination, intellectual ability reduced, irritability, lethargy, overdose effect, psychic disorder, psychosis, somnolence, speech disorder

Epididymitis, erectile impotence, impotence, menstrual disorder, menstrual irregularity, penis disorder, prostate enlarged, vaginal discharge

Abscess, angina tonsillaris, candidiasis, cellulitis, herpes simplex, herpes zoster, infection bacterial, infection mycotic, infection staphylococcal, infestation parasitic, influenza, lymphadenopathy, molluscum contagiosum, moniliasis

Asthma bronchial, bronchitis, cough, dyspnea, epistaxis, hemoptysis, laryngitis, pharyngitis, pneumonia, pulmonary disease, respiratory disorder, rhinitis, rhinitis allergic atopic, sinusitis, upper respiratory tract infection

Blepharitis, conjunctivitis, cytomegalovirus retinitis, dry eye syndrome, earache, ear pressure, eye irritation, hearing decreased, otitis, taste unpleasant, tinnitus, visual disturbance, xerophthalmia

Micturition disorder, nocturia, renal calculus, renal colic, urinary tract bleeding, urinary tract infection

Postmarketing Experience with INVIRASE and Fortovase

Additional adverse events that have been observed during the postmarketing period are similar to those seen in clinical trials with INVIRASE and Fortovase and administration of INVIRASE and Fortovase in combination with ritonavir.

Side Effects by Body System

General

Gastrointestinal side effects have been reported the most frequently with the saquinavir soft gel capsule (SGC) formulation. The saquinavir hard gelatin capsule (HGC) formulation may have better gastrointestinal tolerance. The most common adverse effects associated with saquinavir in combination with other antiretroviral agents have included diarrhea, nausea, abdominal discomfort, and dyspepsia.

Gastrointestinal

Gastrointestinal (GI) side effects have included diarrhea (19.9%), nausea (10.6%), abdominal discomfort (8.6%), dyspepsia (8.4%), flatulence (5.7%), vomiting (2.9%), and abdominal pain (2.3%) during a noncomparative tolerability trial with saquinavir SGC and 2 or more other antiretroviral agents. Other GI side effects have included anorexia, decreased appetite, buccal mucosal ulceration, cheilitis, colic, constipation, dysphagia, esophageal ulceration, esophagitis, eructation, discolored and bloodstained feces, gastralgia, gastroesophageal reflux, gastritis, GI inflammation, gingivitis, GI ulcer, glossitis, hemorrhoids, infectious diarrhea, intestinal obstruction, melena, painful defecation, pancreatitis (including fatalities), parotid disorder, pruritus ani, pyrosis, rectal hemorrhage, salivary gland disorder, stomach upset, stomatitis, taste disturbances, toothache, and tooth disorder.

Cardiovascular

Cardiovascular side effects have rarely included chest pain, cyanosis, edema, heart murmur, heart rate disorder, heart valve disorder, hypertension, hypotension, fatal intracranial hemorrhage, peripheral vasoconstriction, stroke, syncope, thrombophlebitis, and vein distension.

Dermatologic

Dermatologic side effects have included skin rash and pruritus in 2% to 3% of patients. Less common side effects have included acne, alopecia, dermatitis, dry skin and lips, eczema, erythema, exanthema, folliculitis, furunculosis, hair changes, hot flushes, increased sweating, maculopapular rash, nail disorders, night sweats, papillomatosis, photosensitivity reaction, psoriasis, seborrheic dermatitis, skin disorder, skin nodule, skin pigment changes, skin ulceration, urticaria, verruca, and xeroderma.

Endocrine

Endocrine side effects have included increased TSH and, rarely, hyperprolactinemia.

Genitourinary

Genitourinary side effects have included enlarged prostate, epididymitis, impotence, menstrual disorder, menstrual irregularity, micturition disorder, nocturia, pelvic pain, penis disorder, renal calculus, renal colic, urinary tract bleeding, urinary tract infection, and vaginal discharge.

Hematologic

Hematologic side effects have included anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, dermal bleeding, microhemorrhages, and thrombocytopenia leading to death. Spontaneous bleeding in patients with hemophilia A and B has been associated with protease inhibitors. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.

Hepatic

Hepatic side effects have included ascites, sclerosing cholangitis, cholelithiasis, hepatitis, hepatomegaly, hepatosplenomegaly, jaundice, liver enzyme disorder, and elevated ALT, AST, amylase, alkaline phosphatase, gamma glutamyl transpeptidase, and LDH. Severe cutaneous reactions associated with elevated liver function tests, isolated increase in transaminase, and exacerbation of chronic liver disease with Grade 4 elevated liver function tests have been reported. Although a causal relationship has not been established, there have been reports of exacerbation of chronic liver dysfunction, including portal hypertension, in patients with underlying hepatitis B or C, cirrhosis, or other underlying liver abnormalities.

Hypersensitivity

Hypersensitivity side effects have included drug fever, Stevens-Johnson syndrome, and bullous skin eruption and polyarthritis.

Immunologic

Immunologic side effects related to the resistance mechanism have included abscess, angina tonsillaris, bacterial infection, candidiasis, cellulitis, cytomegalovirus retinitis, herpes simplex, herpes zoster, influenza, lymphadenopathy, molluscum contagiosum, moniliasis, mycotic infection, staphylococcal infections, and tumor.

Metabolic

Metabolic side effects have included dehydration, appetite disturbance, hypertriglyceridemia, hyperglycemia, diabetes, hypoglycemia, hypercalcemia, hypocalcemia, hyperphosphatemia, hypophosphatemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia, hyperbilirubinemia, hyperlipidemia, weight decrease, and weight increase.

During postmarketing surveillance, the average time to onset of hyperglycemia and diabetes was 76 days; however, some events occurred as early as 4 days after the initiation of therapy.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, back pain, elevated creatine phosphokinase, leg cramps, muscle cramps, musculoskeletal pain, musculoskeletal disorders, myalgia, stiffness, tissue changes, and trauma.

Nervous system

Nervous system side effects have included headache (5%), and less commonly, ataxia, confusion, convulsions, dizziness, dysarthria, dysesthesia, extremity numbness, face numbness, facial pain, frequent bowel movements, hyperesthesia, hyperreflexia, hyporeflexia, insomnia, lightheadedness, dry mouth, myelopolyradiculoneuritis, paresis, paresthesia, peripheral neuropathy, poliomyelitis, prickly sensation, progressive multifocal leukoencephalopathy, seizures, somnolence, spasms, tremors, unconsciousness, weakness, decreased hearing, and tinnitus.

Ocular

Ocular side effects have included blepharitis, dry eye syndrome, eye irritation, visual disturbance, and xerophthalmia.

Oncologic

Oncologic side effects have rarely included acute myeloblastic leukemia.

Psychiatric

Psychiatric side effects have included agitation, amnesia, anxiety, anxiety attack, depression, euphoria, excessive dreaming, hallucination, irritability, lethargy, libido disorder, psychic disorders, psychosis, reduced intellectual ability, somnolence, speech disorder, and suicide attempt.

Renal

Renal side effects have included nephrolithiasis and acute renal insufficiency.

Respiratory

Respiratory side effects have included bronchitis, cough, dyspnea, epistaxis, hemoptysis, laryngitis, pharyngitis, pneumonia, pulmonary disease, respiratory disorder, rhinitis, sinusitis, and upper respiratory tract infection.

Other

Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement, peripheral wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving protease inhibitors. The mechanism and long-term consequences of these events are currently unknown and a causal relationship has not been established.

Other

Other side effects have included fatigue, fever, intoxication, asthenia, mucosa damage, external parasites, retrosternal pain, shivering, wasting syndrome, generalized weakness, earache, and otitis.

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