Rubraca Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Rubraca Tablet contains rucaparib, a PARP inhibitor used in the treatment of certain ovarian, fallopian tube, primary peritoneal, and prostate cancers. It works by blocking an enzyme that cancer cells use to repair their DNA, which can help slow or stop tumor growth. Rubraca is taken by mouth and requires regular monitoring for certain serious side effects. It is not recommended during pregnancy or breastfeeding.

What is Rubraca Tablet

Rubraca contains the active substance rucaparib. It is an anti-cancer medicine known as a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor.

Rubraca Tablet uses

• Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
• Treatment of adult patients with BRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have already had two or more rounds of chemotherapy
• Maintenance treatment of advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer after response to first-line platinum-based chemotherapy
• Treatment of BRCA mutation-positive metastatic castration-resistant prostate cancer in patients previously treated with androgen receptor-directed therapy

Benefits of Rubraca Tablet

• Treats certain BRCA-mutated recurrent ovarian cancers
• Treats certain BRCA-mutated metastatic castration-resistant prostate cancers
• Can help slow cancer progression
• Provides an oral targeted-treatment option

How Rubraca Tablet works

Rubraca blocks an enzyme called PARP that cancer cells use to repair damaged DNA. By stopping this repair process, the medicine causes damage to build up in the cancer cells, leading to their death, which can slow or stop tumor growth. It works especially well in cancer cells that already have problems repairing DNA, such as those with BRCA gene changes.

Rubraca Tablet dosage

Rubraca is taken by mouth, with or without food. Take the two daily doses about 12 hours apart (for example, once in the morning and once in the evening). If you vomit after taking a dose, do not take another dose — just take your next dose at the regular scheduled time. If you miss a dose, skip it and take your next dose at the usual time; do not double up. Treatment is usually continued until the disease gets worse or side effects become too difficult to manage. No dose change is needed for elderly patients, though some older patients may be more sensitive to side effects.

Available forms and strengths

Film-coated tablets (200 mg, 250 mg, and 300 mg strengths)

Side effects of Rubraca Tablet

Common

• Nausea
• Vomiting
• Fatigue/tiredness or weakness
• Diarrhea
• Constipation
• Abdominal pain or distention
• Changes in sense of taste (dysgeusia)
• Decreased appetite
• Rash
• Increased sensitivity to sunlight (photosensitivity)
• Dizziness
• Shortness of breath
• Headache
• Indigestion (dyspepsia)
• Abnormal liver function test results (AST/ALT elevation)
• Abnormal kidney function test results (increased creatinine)
• High cholesterol

Serious

• Low red blood cell count (anemia) causing tiredness, pale skin, or fast heartbeat
• Low platelet count (thrombocytopenia) causing easy bruising or bleeding
• Low white blood cell count (neutropenia) causing fever or infection
• Myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), serious and potentially fatal bone marrow conditions
• Intestinal obstruction (blockage in the gut or bowel)
• Severe allergic reaction with swelling of the face, lips, tongue, or throat, hives, or difficulty breathing
• Blood in urine or stool

Warnings and precautions

• Rubraca can cause a serious and sometimes fatal bone marrow condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Your doctor will check your blood counts regularly before and during treatment, and may refer you to a blood specialist if there are signs of this condition.
• This medicine can make your skin much more sensitive to sunlight, increasing the risk of sunburn. Avoid direct sunlight and tanning beds, wear protective clothing, and use a high-SPF sunscreen and lip balm.
• Rubraca can cause stomach and bowel problems such as nausea and vomiting, which are usually mild but should be managed promptly to avoid dehydration or hospital stays. A blockage in the intestine has also occurred in some patients, including rare fatal cases.
• Rubraca can harm an unborn baby. Women who can become pregnant must use effective birth control during treatment and for 6 months after the last dose.
• Rubraca is not recommended during pregnancy because it may harm the unborn baby. Women who could become pregnant should have a pregnancy test before starting treatment and should use effective birth control during treatment and for 6 months after the last dose.
• Breastfeeding is not allowed during treatment with Rubraca and for 2 weeks after the last dose, because it is not known if the medicine passes into breast milk and could harm a nursing baby.
• No starting dose change is needed for people with mild or moderate kidney problems. The medicine has not been studied in people with severe kidney impairment, and these patients should be carefully monitored.
• No starting dose change is needed for people with mild or moderate liver problems, though those with moderate impairment should be closely monitored. The medicine is not recommended for people with severe liver impairment because it hasn't been studied in this group.
• Rubraca may affect your ability to drive or use machines, especially if you feel tired, sick to your stomach, or dizzy. Be careful when driving or using tools or machines if you have these symptoms.

Storage

• Store below 25°C
• Use within 30 days after first opening the bottle, and continue to store below 25°C
• Store at room temperature away from moisture and heat
• Keep out of the sight and reach of children
• Do not throw away medicines via wastewater or household waste; ask your pharmacist how to dispose of medicines you no longer use

When to see a doctor

• Get emergency medical help right away if you have signs of a serious allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
• Call your doctor right away if you notice blood in your urine, or signs of low blood cell counts such as fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, or feeling light-headed or short of breath.
• If you think you have taken too much of this medicine, seek emergency medical attention right away.
• Tell your doctor straight away if a pregnancy occurs while taking this medicine, since it could harm the baby.

Alternatives

• Olaparib
• Niraparib
• Talazoparib