Applies to rucaparib: oral tablet.

Serious side effects of Rucaparib

Along with its needed effects, rucaparib 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 rucaparib:

More common

• Black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine
• body aches or pain
• chills
• cough
• difficulty in breathing
• ear congestion
• fever
• headache
• loss of voice
• lower back or side pain
• muscle aches
• nasal congestion
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rapid weight gain
• sneezing
• sore throat
• stuffy or runny nose
• tingling of the hands or feet
• trouble breathing
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Less common

• Redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• tenderness of the palms and soles
• tingling of the hands and feet
• ulceration of the skin

Other side effects of Rucaparib

Some side effects of rucaparib 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

• Belching
• change in taste
• constipation
• decreased appetite
• diarrhea
• discouragement
• dizziness
• feeling sad or empty
• heartburn
• increased sensitivity of the skin to sunlight
• indigestion
• irritability
• itching, skin rash
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• loss of taste
• nausea
• redness or other discoloration of the skin
• severe sunburn
• stomach discomfort, upset, or pain
• stomach distention
• swelling or inflammation of the mouth
• trouble concentrating
• trouble sleeping
• vomiting

For Healthcare Professionals

Applies to rucaparib: oral tablet.

General

The most common adverse reactions in patients with ovarian cancer were nausea, fatigue/asthenia, anemia, abdominal pain, increased ALT, increased AST, vomiting, diarrhea, decreased appetite, thrombocytopenia, dysgeusia, neutropenia, increased blood creatinine, dyspnea, dizziness, dyspepsia, photosensitivity reaction, and leukopenia.

The most common adverse reactions in patients with BRCA (breast cancer gene)-mutated metastatic castration-resistant prostate cancer (mCRPC) were fatigue/asthenia, nausea, anemia, increased ALT, increased AST, decreased appetite, rash, constipation, thrombocytopenia, vomiting, and diarrhea.^[Ref]

Cardiovascular

Frequency not reported: ECG QT prolonged, cardiac failure, ischemic cardiovascular events, venous thromboembolism

Dermatologic

Very common (10% or more): Rash (includes blister, blood blister, dermatitis, contact dermatitis, eczema, genital rash, palmar-plantar erythrodysesthesia syndrome, photosensitivity reaction, psoriasis, rash, maculopapular rash, pruritic rash, skin exfoliation, skin lesion, urticaria; up to 45%), photosensitivity reaction (up to 12%)

Common (1% to 10%): Maculopapular rash, palmar-plantar erythrodysesthesia syndrome, erythema, pruritus

Pruritus was reported in 14% of patients 75 years and older compared with 9% of patients younger than 75 years.

Gastrointestinal

Very common (10% or more): Nausea (up to 79%), abdominal pain (includes abdominal pain, abdominal distention, lower abdominal pain, upper abdominal pain; up to 48%), constipation (up to 39%), vomiting (up to 37%), diarrhea (up to 34%), stomatitis (up to 28%), dyspepsia (up to 12%)

Common (1% to 10%): Intestinal obstruction (includes intestinal obstruction, large intestinal obstruction, small intestinal obstruction)

Genitourinary

Frequency not reported: Urinary tract infection

Hematologic

Anemia and thrombocytopenia (grade 3 or higher) were reported in 31% and 10%, respectively, of patients with moderate renal dysfunction (CrCl 30 to 59 mL/min) compared with 21% and 5%, respectively, of patients with normal renal function (CrCl greater than 90 mL/min).

The time of onset for myelosuppression (grade 3 or higher) was generally later in treatment (after 2 or more months).

Very common (10% or more): Decreased leukocytes (up to 69%), decreased absolute neutrophil count (includes decreased neutrophils; up to 62%), decreased hemoglobin (up to 61%), decreased platelets (up to 47%), anemia (up to 45%), decreased lymphocytes (up to 42%), thrombocytopenia (includes decreased platelet count; up to 35%), neutropenia (up to 22%), leukopenia (includes decreased WBC count; 10%)

Common (1% to 10%): Lymphopenia, febrile neutropenia

Frequency not reported: Bleeding, myelosuppression

Hepatic

Events related to increases in ALT and AST occurred within the first few weeks of therapy, were reversible, and were rarely associated with increases in bilirubin.

Increased ALT/AST combined (grade 3 or higher) was reported in 12% of patients with moderate renal dysfunction compared with 7% of patients with normal renal function.

Very common (10% or more): Increased ALT (up to 69%), increased AST (up to 59%), increased ALT/AST (up to 39%)

Common (1% to 10%): Increased transaminases

Frequency not reported: Increased bilirubin

Hypersensitivity

Common (1% to 10%): Hypersensitivity (include hypersensitivity, drug hypersensitivity, swelling/edema of the face, swelling/edema of the eyes/periorbital swelling, flushing, asthma, choking sensation, wheezing)

Metabolic

Very common (10% or more): Decreased appetite (up to 28%)

Common (1% to 10%): Hypophosphatemia, hypercholesterolemia, dehydration

Nervous system

Dizziness and memory impairment were reported in 19% and 4%, respectively, of patients 75 years and older compared with 13% and 1%, respectively, of patients younger than 75 years.

Very common (10% or more): Dysgeusia (up to 33%), headache (up to 22%), dizziness (up to 15%)

Common (1% to 10%): Memory impairment

Frequency not reported: Balance disorder

Oncologic

MDS/AML has occurred in patients treated with this drug. In 1594 treated patients with ovarian cancer, MDS/AML occurred in 32 patients, including those in long term follow-up; of these, 14 occurred during therapy or during the 28-day safety follow-up. The duration of therapy before the diagnosis of MDS/AML ranged from less than 2 to about 72 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents.

In a study of patients with a germline and/or somatic BRCA mutation, MDS/AML occurred in 9 out of 129 patients treated with this drug. The duration of therapy in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.

Common (1% to 10%): Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)

Other

Very common (10% or more): Fatigue (includes fatigue, asthenia, lethargy; up to 74%), decreased phosphate (up to 68%), increased alkaline phosphatase (up to 44%), increased triglycerides (up to 42%), increased cholesterol (up to 39%), decreased sodium (up to 38%), pyrexia (up to 15%), peripheral edema (up to 12%)

Frequency not reported: Decreased weight, sepsis

Fatigue/asthenia (grade 3 or higher) was reported in 13% of patients with moderate renal dysfunction compared with 8% of patients with normal renal function.

Psychiatric

Very common (10% or more): Insomnia (up to 19%), depression (up to 11%)

Renal

Very common (10% or more): Increased blood creatinine (up to 96%)

Common (1% to 10%): Acute kidney injury

Frequency not reported: Renal failure

Increases in serum creatinine, primarily mild to moderate (grade 1 or 2), were observed in 20% of patients within the first few weeks of therapy. These increases in serum creatinine were clinically asymptomatic.

Increased blood creatinine was reported in 33% of patients 75 years and older compared with 18% of patients younger than 75 years.

Respiratory

Very common (10% or more): Nasopharyngitis/upper respiratory tract infection (up to 29%), dyspnea (up to 17%)

Frequency not reported: Acute respiratory distress syndrome, pneumonia