Applies to lonafarnib: oral capsule.

Serious side effects of Lonafarnib

Along with its needed effects, lonafarnib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lonafarnib:

More common

• Agitation
• black, tarry stools
• blood in the urine or stools
• burning, dry, or itching eyes
• changes in the eye
• coma
• cough or hoarseness
• confusion
• dark urine
• decreased appetite
• decreased urine output
• depression
• diarrhea
• discharge, excessive tearing
• dizziness
• fever
• headache
• irritability
• lethargy
• light-colored stools
• lower back or side pain
• muscle twitching
• nausea
• painful or difficult urination
• pinpoint red spots on the skin
• rapid weight gain
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• seizures
• sore throat
• stomach pain or bloating
• stupor
• swelling of the face, ankles, or hands
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weight loss
• yellow eyes or skin

Less common

• Body aches or pain
• chills
• cough
• difficulty in breathing
• ear congestion
• fever
• headache
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat

Other side effects of Lonafarnib

Some side effects of lonafarnib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bloated
• bloody nose
• constipation
• excess air or gas in the stomach or bowels
• full feeling
• passing gas

Less common

• Cracked lips
• difficulty in swallowing
• itching skin
• sores, ulcers, or white spots in the lips, tongue, or inside the mouth

For Healthcare Professionals

Applies to lonafarnib: oral capsule.

General

The more commonly reported adverse reactions have included gastrointestinal reactions, fatigue, infection, and laboratory abnormalities.^[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (90%), diarrhea (81%), nausea (56%), abdominal pain (48%), constipation (22%)

Common (1% to 10%): Flatulence

Gastrointestinal (GI) adverse reactions were the most frequently reported adverse reactions in clinical trials. Vomiting was reported as mild, moderate, or severe in 30 (53%), 26 (46%) in 1 (2%) of patients, respectively. Nausea was reported as mild or moderate in 34 (97%) and 1 (3%) patient, respectively. Four patients discontinued therapy mostly due to nausea or vomiting. For patients experiencing diarrhea, the majority reported it as mild or moderate.

Hematologic

Very common (10% or more): Myelosuppression

Myelosuppression includes absolute neutrophil count decreased, low total white blood cells, lymphopenia, decreased hemoglobin, and hematocrit low.

Immunologic

Infection includes abdominal infection, candidiasis, chicken pox, Clostridium difficile colitis, colitis, croup, dengue fever, flu syndrome, flu-like symptoms, fungal infection, gastroenteritis, gastrointestinal infection, Helicobacter pylori infection, infection, infection viral, influenza, nail infection, otitis media, parotitis, perirectal abscess, pneumonia, small intestine infection, submandibular lymphadenitis, tonsillitis, viral infection.

Very common (10% or more): Infection (78%)

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (48%)

Musculoskeletal pain includes arthritis, back pain, bone pain, foot pain, intercostal pain, joint pain, knee pain, leg pain, musculoskeletal pain, pain in ankle/extremity/fingers/hip/leg/limb/lower limbs/left arm, shoulder pain, unilateral leg pain. Excludes musculoskeletal pain for abdomen.

Ocular

Very common (10% or more): Ocular changes (24%)

Ocular changes include visual acuity change, corneal clouding, conjunctivitis, watering eyes, keratitis.

Metabolic

Very common (10% or more): Decreased appetite (53%), electrolyte abnormalities (43%), decreased weight (37%), decreased blood bicarbonate (33%)

Common (1% to 10%): Dehydration

Electrolyte abnormalities include hypermagnesemia, hypokalemia, hyperkalemia, hyponatremia, hypercalcemia, hyperphosphatemia, hypocalcemia, and hypernatremia.

Psychiatric

Common (1% to 10%): Depressed mood

Hepatic

Very common (10% or more): Elevated alanine aminotransferase (27%), elevated aspartate aminotransferase (35%)

Respiratory

Upper respiratory infection includes bronchial infection, bronchitis, sinus infection, and upper respiratory infection.

Very common (10% or more): upper respiratory tract infection (51%), rhinitis (19%), cough (33%), epistaxis (21%)

Other

Very common (10% or more): Fatigue (51%), pyrexia (14%)

Nervous system

Very common (10% or more): Headache (37%), cerebral ischemia (11%)

Cerebral ischemia includes cerebral ischemia, central nervous system hemorrhage, and ischemia cerebrovascular.

Cardiovascular

Increased blood pressure (BP) has been reported. At baseline 22 (35%) patients had a systolic or diastolic or both above the 95th percentile. During clinical studies, 18 (29%) patients had hypertension based on systolic or diastolic BP being above the 95th percentile on 3 or more occasions. Five (8%) patients who were normotensive at baseline had either systolic blood pressure or diastolic blood pressure above the 95th percentile at the end of treatment.

Very common (10% or more): Hypertension (29%)

Dermatologic

Very common (10% or more): Rash (11%)

Common (1% to 10%): Pruritus, mucositis