Niraparib (Zejula; Akeega combination)

Niraparib at a glance

Niraparib belongs to a group called PARP inhibitors. It is often prescribed as maintenance treatment: treatment intended to help keep a cancer response going after other treatment has worked. Treatment usually continues while it is controlling the cancer and side effects remain acceptable, with regular specialist reassessment. Benefit and treatment duration vary between individuals. It cannot guarantee that cancer will not return or grow.

Zejula is taken once daily. Common starting doses are 200 mg or 300 mg, but your prescription depends on the treatment setting, blood counts, weight and liver function. Tablets and capsules do not all have the same food instructions. Check the exact product supplied.

The main safety priorities are low blood counts, bleeding or infection, raised blood pressure and a rare serious brain condition called PRES. A longer-term risk is a serious bone-marrow disorder. Regular tests remain important even when you feel well.

What niraparib is and how it works

DNA contains instructions that cells need to function. Cells continually repair DNA damage. PARP proteins help with part of this repair process. Niraparib blocks their activity and can trap PARP on damaged DNA, making repair more difficult. Cancer cells with certain existing repair weaknesses may be particularly vulnerable. Healthy cells can also be affected, which helps explain side effects.

BRCA1 and BRCA2 are genes involved in another DNA-repair pathway. A harmful change in either gene can weaken that pathway. Homologous recombination deficiency, or HRD, is a broader description of difficulty with this repair system. A BRCA change and an HRD result are related concepts, but they are not interchangeable test results.

An inherited BRCA change may also matter to relatives. A change found only in a tumour does not automatically mean it is inherited. Your team can explain whether a separate inherited-gene test and genetic counselling are appropriate.

How the team decides whether it is suitable

Your oncologist considers your diagnosis, response to previous treatment, relevant BRCA or HRD results, blood counts, other health conditions and the current prescribing information. Selection rules have changed over time. Current US Zejula information includes biomarker restrictions that are not identical to European information; an older webpage saying everyone is eligible should not determine your treatment.

The team also weighs potential benefit against previous bone-marrow damage, continuing side effects from chemotherapy, heart or blood-pressure problems, and your preferences. Having a particular test result does not by itself establish that niraparib is the best choice. Ask what the realistic aim is in your situation and how it will be assessed.

Moderate liver impairment can require a 200 mg starting dose for Zejula. Evidence is limited in severe liver impairment or severe kidney impairment, including dialysis. Safety and effectiveness in children have not been established. These situations need individual specialist decisions.

Before treatment starts

A full blood count measures haemoglobin, infection-fighting white cells and platelets, which help stop bleeding. Blood-count side effects from previous chemotherapy should have recovered sufficiently before starting. The team checks liver and kidney function and measures blood pressure; high blood pressure should be controlled.

Tell the team about previous unexplained low blood counts, blood disorders, bleeding, heart disease, palpitations, stroke, seizures and all medicine allergies. Bring a full list of prescription medicines, non-prescription products, vitamins and herbal remedies. Blood thinners and diabetes medicines deserve particular attention.

Pregnancy testing is required before treatment when pregnancy is possible. Discuss contraception and fertility before the first dose. Obtain your hospital's urgent advice arrangements and its temperature instructions. Keep a thermometer at home. If home blood-pressure checks are planned, ask the nurse to demonstrate the cuff and explain which readings or symptoms require contact.

How treatment is taken

Dose and daily routine

Take the whole prescribed Zejula dose together once daily, at roughly the same time. In the setting where the starting dose is individualised, a weight below 77 kg OR a platelet count below 150,000 per microlitre leads to a 200 mg starting dose. A 300 mg starting dose requires both weight at least 77 kg AND platelets at least 150,000.

Other maintenance plans use a 300 mg starting dose; European information also allows consideration of 200 mg for some patients weighing below 58 kg in that context. These are prescribing decisions, not rules for adjusting your own dose when your weight changes. The team may subsequently pause treatment or reduce it to 200 mg or 100 mg because of side effects.

US Zejula tablets contain 100 mg, 200 mg or 300 mg each. The reviewed European tablets and capsules each contain 100 mg. Count tablets or capsules according to your dispensing label, not another patient's routine. Taking the dose at bedtime may help nausea, provided the correct food instructions are followed.

Food and swallowing: check the formulation

US Zejula tablets may be taken with or without food. European Zejula capsules may also be taken with or without food. European Zejula tablets are taken without food, at least one hour before or two hours after a meal, OR with a light meal. A large or fatty meal should not be substituted for that light-meal option. Confirm which instructions apply whenever the supplied product changes.

Swallow the medicine whole with water. Do not chew or crush it; US tablets must not be split. If swallowing is difficult or you use a feeding tube, contact the oncology pharmacist. The reviewed information does not provide a home-made dispersion or feeding-tube method. Do not open capsules or alter tablets on your own.

Missed doses, vomiting and storage

For Zejula, do not take an extra dose after missing a dose or vomiting. Take the next dose at the usual scheduled time. Never double the dose. Contact the team if vomiting persists, you cannot keep fluids down, or repeated missed doses are making treatment difficult. If you take too much, obtain urgent medical advice.

Keep medicine in its original packaging, away from children, and follow the storage temperature on your particular pack. European capsules must not be stored above 30°C (86°F); tablet storage instructions differ. Ask the pharmacy how to manage hot-weather travel. Return unused medicine to a pharmacy using its disposal arrangements.

Akeega is a different product

Akeega contains niraparib plus abiraterone acetate, which reduces production of certain hormones. It is not a simple substitute for Zejula. Its prescribed corticosteroid, such as prednisone, is an essential part of the plan and should not be stopped abruptly. Illness or surgery may require a clinician-directed steroid adjustment. Report severe weakness, dizziness or fainting urgently because inadequate steroid levels can be dangerous. Other hormone treatment may also be required.

US Akeega instructions require an empty stomach: at least one hour before or two hours after food. Swallow tablets whole. A missed dose is taken as soon as possible on the same day, then the usual schedule resumes the following day. This differs from Zejula. Follow the combination-specific plan for vomiting or multiple missed doses. Its additional liver, potassium, fluid-retention, blood-sugar and steroid precautions require its own monitoring schedule. Report yellow skin or eyes, dark urine, rapid swelling or new breathlessness promptly. Moderate liver impairment that permits a lower Zejula dose does not make Akeega suitable; US guidance avoids Akeega in moderate or severe liver impairment. Anyone who is pregnant or could become pregnant should use protection, such as gloves, when handling Akeega tablets.

Monitoring and checking whether treatment is working

Blood counts

For Zejula, blood counts are checked weekly during the first month. US information then specifies monthly checks for the next 11 months; European information specifies the next 10 months, with more frequent testing when necessary. Periodic checks continue afterwards. Do not assume testing can stop after the first year.

A low result may lead to a treatment pause, repeat weekly tests, a lower dose or supportive treatment such as transfusion. Platelets below 100,000 per microlitre are one label-defined reason to withhold Zejula. These results need clinical interpretation; do not use one number from an online portal to stop or restart treatment yourself.

If blood counts do not recover adequately after a treatment interruption, the specialist investigates further. Persistent abnormalities may require a haematologist, a doctor specialising in blood disorders, and a bone-marrow examination. This investigation does not itself mean you have developed another cancer.

Blood pressure, pulse and response

Blood pressure should be checked at least weekly during the first two months, monthly during the first year and periodically afterwards. US information also specifies heart-rate monitoring on that schedule. Home measurements may supplement clinic checks when the team provides a plan.

Other blood tests and symptom reviews are tailored to your health and medicines. Scans and, when useful, tumour-marker trends help assess whether treatment is achieving its aim. A single symptom or marker result cannot reliably tell you whether niraparib is working.

Common side effects and practical management

Nausea, vomiting and reduced appetite

Take prescribed anti-sickness medicine as directed rather than waiting until nausea becomes severe. Small, manageable meals and regular sips of fluid may help, while keeping the product's dose-and-food rules. Tell the team if appetite loss or altered taste is causing weight loss. Repeated vomiting, dizziness or reduced urine can indicate dehydration and need prompt advice.

Constipation, diarrhoea and abdominal discomfort

Constipation is a common problem and can be worsened by some anti-sickness medicines. Gentle activity, adequate fluids and suitable fibre may help when tolerated. Ask about a laxative early if needed. Severe abdominal pain, a swollen abdomen, repeated vomiting or inability to pass wind requires urgent assessment rather than simply taking more laxative.

For diarrhoea, keep drinking and use only the treatment agreed with your team. Contact them if it persists, is accompanied by fever or blood, or makes you feel weak or dehydrated.

Tiredness, sleep and aches

Fatigue may come from treatment, anaemia, poor sleep or the cancer itself. Balance rest with gentle movement and prioritise important activities. New marked breathlessness, dizziness or a racing heart should not be dismissed as ordinary tiredness. They may signal anaemia or another problem.

Headache, back or muscle aches and difficulty sleeping can occur. Check before taking painkillers, particularly ibuprofen or aspirin when platelets are low. Tell the team about persistent symptoms so they can check the cause and suggest suitable treatment. Sudden severe headache or headache with visual or neurological symptoms needs emergency assessment.

Mouth, taste and skin changes

A soft toothbrush, gentle oral care and bland foods can help a sore or dry mouth. Report ulcers that prevent drinking. Skin rash and sensitivity to sunlight may occur; use sun protection and report troublesome changes. A widespread rash with facial swelling or breathing difficulty requires emergency help.

Less common but important side effects

Low blood counts, infection and bleeding

Low red cells cause anaemia, which may produce fatigue, pallor, breathlessness or palpitations. Low white cells increase infection risk. Low platelets can cause easy bruising, tiny red or purple skin spots, nosebleeds or prolonged bleeding. These changes can be serious even when an early blood test is the only sign.

Contact the hospital immediately for fever, shaking chills, burning urine, a new cough with illness, or sudden deterioration. Serious infection can occur without a high temperature. Uncontrolled bleeding, vomiting blood, black stools or collapse needs emergency care.

High blood pressure and heart symptoms

Niraparib can raise blood pressure, sometimes severely. It may also cause palpitations or a fast heartbeat. Continue prescribed blood-pressure medicines and report new symptoms or readings outside your team's limits. A normal feeling does not rule out hypertension. Severe chest pain, breathlessness, stroke symptoms or collapse needs emergency care. The team may adjust treatment; European guidance requires stopping Zejula for a hypertensive crisis or medically significant hypertension that cannot be adequately controlled.

PRES: a serious neurological condition

Posterior reversible encephalopathy syndrome, or PRES, involves swelling in the brain. Possible symptoms include a seizure, severe headache, confusion, altered alertness or blurred or lost vision. It can occur with or without high blood pressure.

Seek emergency care immediately for these symptoms, take no further dose while obtaining assessment, and tell staff you take niraparib. US Zejula guidance requires prompt discontinuation when PRES is suspected; brain imaging, preferably MRI, helps confirm it. Although the name includes “reversible”, recovery is not guaranteed. The safety of restarting after PRES is unknown; do not restart yourself.

MDS and acute myeloid leukaemia

Myelodysplastic syndrome, or MDS, is a disorder in which the bone marrow produces abnormal blood cells. Acute myeloid leukaemia, or AML, is a blood cancer. Both have occurred in patients receiving niraparib, sometimes with fatal outcomes. Previous platinum chemotherapy and other DNA-damaging treatments may also contribute to risk.

This is a serious longer-term risk affecting a minority of patients; estimates vary between study populations and follow-up periods. Persistent low counts, unusual bruising, recurrent infection or worsening fatigue need investigation. Ordinary treatment-related anaemia does not automatically mean MDS or AML. Confirmed MDS or AML requires permanent discontinuation and specialist management.

Lung inflammation

Non-infectious lung inflammation has been reported. A new or worsening cough, breathlessness or fever needs prompt assessment because infection, anaemia and other conditions can cause similar symptoms. Severe breathing difficulty is an emergency.

Other medicines, supplements and vaccinations

Do not start or stop another medicine without an interaction check. European Zejula information identifies potential interactions with medicines including dabigatran, certain statins, methotrexate, clozapine, theophylline and ropinirole. Several concerns come from laboratory evidence rather than completed clinical interaction studies; the pharmacist must interpret their importance for you.

Niraparib may increase exposure to metformin. Closer blood-glucose checks can be needed when niraparib starts or stops, and the metformin dose may need adjustment. Blood thinners and antiplatelet medicines also need review because low platelets increase bleeding risk; do not discontinue them yourself.

Akeega has additional interaction rules because it also contains abiraterone. Its pharmacist review must cover both ingredients. Bring herbal, supplement and non-prescription products too.

Discuss vaccinations with the team, particularly live vaccines or vaccination during low blood counts. The right timing depends on your immune recovery and other treatments. Do not assume advice for another PARP inhibitor, including food restrictions or medicine spacing, automatically applies to your product.

Everyday life during treatment

Work and activity can often continue with adjustments for fatigue and clinic visits. Build up exercise gradually and rest when needed. Do not drive or operate machinery if dizzy, unusually tired, confused or experiencing visual symptoms.

Plan travel around blood tests and reliable medicine supply. Carry the labelled original pack, your medicine list and urgent contact details, and discuss access to medical care at your destination. Check storage needs before travelling in hot weather.

Tell your dentist and other clinicians about niraparib before procedures. Low platelets or white cells may affect timing. There is no single treatment-break rule suitable for every operation; the oncology team should coordinate any interruption.

European capsules contain tartrazine, a colouring that can cause allergic reactions, whereas the reviewed European tablets do not contain it. Zejula products contain lactose; tell the pharmacist about a diagnosed inherited sugar-intolerance disorder or excipient allergy. Emotional support and help with sleep or sexual concerns are also part of care.

Fertility, contraception, pregnancy and breastfeeding

Niraparib can harm an unborn baby. Effective contraception is needed for patients who could become pregnant throughout Zejula treatment and for six months after the final dose; European information specifies a highly effective method. Contact the team promptly if pregnancy occurs or is suspected.

Do not breastfeed during Zejula treatment or for one month after the last dose. Discuss fertility preservation before starting when relevant. Animal findings suggest possible effects on male fertility, but they do not reliably predict whether an individual will become infertile or recover fertility.

The reviewed Zejula labels do not give a fixed male contraception interval. Do not invent one from another PARP inhibitor. US Akeega information does specify effective contraception for male patients with a partner who could become pregnant during treatment and for four months afterwards. Follow the complete product and accompanying-treatment advice; one medicine's interval must not shorten another's precaution.

After treatment finishes

Continue blood tests and other follow-up as arranged, especially if treatment stopped because of low counts or high blood pressure. Contact the team for persistent bruising, infections, fatigue or breathlessness rather than assuming all symptoms will immediately disappear. Investigation of abnormal counts may continue after tablets stop.

Keep contraception and breastfeeding precautions for their full stated intervals. Review interacting medicines when niraparib stops, particularly metformin. Return leftover medicine to the pharmacy; do not restart a previous dose after a long interruption without checking the current plan.

Frequently asked questions