1. What is alpelisib?
Alpelisib is a targeted therapy. Targeted therapies block the growth and spread of cancer. They target and interfere with processes in cells that help cancer grow.
Alpelisib belongs to a group of drugs called PI3K (phosphatidylinositol-3-kinase) inhibitors.
Alpelisib is the drug’s non-branded name. You may hear it called by its brand name Piqray.
2. Who might be offered alpelisib?
You may be offered alpelisib if you have or that’s:
- Oestrogen receptor positive (ER-positive)
- HER2-negative
- And has changes (mutations) in a gene called PIK3CA
It’s given alongside the hormone therapy drug fulvestrant.
Before having alpelisib, you should have already had hormone therapy alongside a CDK 4/6 inhibitor (abemaciclib, palbociclib or ribociclib).
Alpelisib is not given for , though clinical trials are looking at whether it may be useful.
Testing for PIK3CA gene mutations
A PIK3CA mutation is not inherited (it cannot be passed on). It’s more common in ER-positive and HER2-negative breast cancer.
ER-positive breast cancers can be tested for a PIK3CA mutation. This is done in a laboratory on a sample of breast cancer tissue removed during a .
If the biopsy shows that your breast cancer has a PIK3CA mutation, you may be offered alpelisib as part of your treatment.
3. How alpelisib works
Alpelisib works by targeting breast cancer cells that have a PIK3CA mutation.
In breast cancers with a PIK3CA gene mutation, a protein called PI3K helps the cancer cells multiply and grow.
Alpelisib helps stop the growth and spread of the cancer by blocking the action of PI3K.
4. How alpelisib is taken
You take alpelisib as tablets once a day.
The usual dose of alpelisib is 300mg, taken as two 150mg tablets.
You should swallow the tablets whole with water. Do not crush, chew or dissolve them. You should take them after food, around the same time each day.
Fulvestrant is given as 2 injections, 1 in each buttock. Fulvestrant is usually given every 14 days for the first 3 doses, then every 28 days for as long as you are having alpelisib.
What if I miss a dose?
If you miss a dose, you can take alpelisib immediately within 9 hours after the time you usually take it.
After more than 9 hours, skip the dose. Take the next dose at your usual time.
If you are sick (vomit) after taking alpelisib, do not take an extra dose. Take your next dose at your usual time.
How long will I take alpelisib?
You’ll have alpelisib for as long as your treatment team feels you’re benefiting from the drug and any side effects are manageable.
Alpelisib and menopause
Fulvestrant is suitable for women who have been through the menopause (when your periods stop).
If you have not been through the menopause, you will also have treatment to stop your ovaries producing oestrogen, either temporarily or permanently. This is known as ovarian suppression.
5. Side effects of alpelisib
Like any drug, alpelisib can cause side effects.
Everyone reacts differently to drugs and some people have more side effects than others. These side effects can usually be managed and those described here will not affect everyone.
Because it’s given alongside fulvestrant, you may also have side effects from that drug.
If you’re worried about any side effects, regardless of whether they’re listed here, talk to your treatment team.
Your treatment team can often change the dose of a drug to suit you and to help manage its side effects. This can sometimes help you stay on a treatment for longer.
You should be given a 24-hour contact number or told who to contact if you feel unwell or are concerned about side effects at any time, including at night or at the weekend.
Common side effects
Raised blood sugar levels
Alpelisib can cause your blood sugar levels to increase (hyperglycaemia).
Let your treatment team know if you’re more thirsty or peeing more often than usual.
Other symptoms may include:
- Feeling more tired than usual
- Increased appetite but with weight loss
- Confusion
- Feeling sick (nausea)
- Being sick (vomiting)
- A fruity smell on your breath
- Difficulty breathing
- Flushed skin
You’ll be asked to have regular fasting blood sugar tests. These check the level of sugar (glucose) in your blood after you haven’t eaten or drunk anything except water for a certain time, usually 8 to 10 hours.
You may be asked to test your blood sugar levels at home. Your treatment team will show you how to do this.
Skin changes
Alpelisib may cause skin changes. Some of them may be severe, including:
- Dry skin
- Rash
- Blistering
- Itching
- Reddening of the skin
- Hand-foot (palmar plantar) syndrome
Your treatment team can suggest drugs, such as antihistamines, to reduce any itching.
Less commonly, skin changes may be accompanied by flu-like symptoms.
It may help to:
- Use a moisturiser regularly and avoid perfumed products
- Wear gloves when washing up, using harsh detergents, gardening or cooking
- Rinse and dry your hands carefully, particularly after contact with cleaning products
- Pat your skin dry with a soft towel, rather than rubbing vigorously
- Take care when shaving
- Wear cotton clothes where possible and wash clothes in mild detergent
Diarrhoea
Diarrhoea is a very common side effect of alpelisib and can sometimes be severe.
Your treatment team or GP may prescribe anti-diarrhoea medication to take home.
Contact your treatment team if you have diarrhoea 3 or more times in 24 hours, compared to what’s usual for you.
Nausea and vomiting
You may feel sick (nausea) and be sick (vomit).
Your treatment team can prescribe anti-sickness drugs to help with this. If you’re still feeling or being sick after taking them, contact your treatment team. They may be able to prescribe a different anti-sickness drug.
Try to eat small regular meals if possible and drink plenty of fluids.
Loss of appetite
You may not feel like eating, especially if you feel sick.
Your sense of taste can also change, and some foods and drinks may taste different.
It might help to eat small meals regularly and drink plenty of fluids. You can ask your GP or treatment team to refer you to a dietitian for more advice.
Find out more about diet and breast cancer treatment.
Effects on the blood
Alpelisib can temporarily affect the number of blood cells in the body. Blood is made up of red cells, white cells and platelets.
You’ll have regular blood tests. If these show the number of blood cells is too low, your next cycle of treatment may be delayed or the dose reduced.
Risk of infection
Not having enough white blood cells can increase your risk of getting an infection.
Signs of an infection
Your treatment team may give you advice on reporting signs of an infection. But generally you should contact your hospital immediately if you have any of the following:
- A high temperature (over 37.5°C) or low temperature (under 36°C)
- Suddenly feeling unwell, even with a normal temperature
- Symptoms of an infection, such as a sore throat, cough, needing to pee often or feeling cold or shivery, even if you do not have a high temperature
Before starting alpelisib, you should be given a 24-hour contact number or told who to contact if you feel unwell at any time during your treatment, including overnight or at the weekends.
You may need treatment if you get an infection.
Sometimes your treatment team may recommend injections of drugs called growth factors. This helps the body produce more white blood cells to reduce your risk of infection.
Anaemia
Having too few red blood cells is called anaemia. If you feel breathless, dizzy or particularly tired, let your treatment team know.
Bruising and bleeding
Alpelisib can reduce the number of platelets. Platelets help the blood to clot.
If your platelets are low, you may:
- Bruise more easily
- Have nosebleeds
- Notice that your gums bleed when you brush your teeth
- Take longer to stop bleeding it you cut yourself
Tell your treatment team if you have any of these symptoms.
Extreme tiredness (cancer-related fatigue)
Cancer-related fatigue is one of the most common symptoms in people with secondary breast cancer.
Fatigue is extreme tiredness that does not go away with rest or sleep. It has many causes, from the emotional impact of a diagnosis to side effects of treatment or growth and spread of the cancer.
Fatigue may affect how you cope with your cancer and its treatment. It can also make everyday activities harder and affect your quality of life.
Find out more about managing fatigue.
Hair thinning or hair loss
Hair thinning and hair loss are very common when taking alpelisib with fulvestrant.
Find out more about breast cancer and hair loss.
Sore mouth
Looking after your mouth, including your teeth and gums, is very important during treatment.
You’ll be given mouthwash to try to reduce soreness and stop mouth ulcers developing. It’s a good idea to use a small, soft toothbrush during this time.
See your dentist for a check-up before treatment begins. Avoid dental work during treatment if possible.
If you do need to have dental work during treatment, talk with your treatment team about the best time to have this.
If you’re having difficulty registering with a dentist, let your treatment team know.
Other common side effects
Other common side effects of alpelisib include:
- Headaches
- Weight loss
- Tummy (abdominal) pain
- Indigestion
- Swelling (oedema) particularly of the hands and legs
- High temperature
Your treatment team can advise you on how to manage these.
Less common side effects
Damage to the lungs
Alpelisib can affect the lungs.
Contact your treatment team straight away if you have:
- Shortness of breath
- A cough, with or without a high temperature
- Any new or worsening breathing problems, such as chest tightness or wheezing
These symptoms could be due to scarring or inflammation of the lungs caused by alpelisib. Or they may have another cause, such as a lung infection.
You may need a chest x-ray or CT scan to check what’s causing your symptoms.
If alpelisib has caused inflammation to your lungs, you may need to stop treatment temporarily and have steroids to treat the inflammation.
Osteonecrosis of the jaw
Osteonecrosis is a condition where a loss of blood flow to bone tissue causes the bone to die. It’s a less common but serious long-term side effect of alpelisib.
It can affect the jaw, causing symptoms such as:
- Lasting jaw pain
- Loose teeth
- Swelling, redness or ulcers on the gums
Looking after your mouth, including your teeth and gums, can help reduce the risk.
Less commonly, osteonecrosis can affect the ear.
If you have any ear pain, discharge from your ear or an ear infection while taking alpelisib contact your treatment team.
Alpelisib is not recommended if you already have osteonecrosis of the jaw from other treatments such as bone-strengthening drugs.
Other less common side effects
Other less common side effects of alpelisib include:
- Dehydration
- Kidney problems
- Blurred vision and dry eyes
- Difficulty sleeping (insomnia)
- High blood pressure
- Toothache, gum disease, gum pain and inflammation of the lips
- Muscle aches, pains and spasms
6. Other important information
Allergic reaction
It’s possible to have an allergic reaction to alpelisib. Reactions can vary from mild to severe.
If you have an allergic reaction to alpelisib, it’s more likely to happen the first time you have the treatment.
Contact your hospital immediately if you notice any of the following symptoms:
- Itchy red or discoloured bumps on your skin (these may be harder to see on black or brown skin)
- Swelling in your lips, tongue or throat
- Breathlessness, wheezing, a bad cough or sudden difficulty breathing
- Tight chest or chest pain
Blood clots
People with breast cancer have a higher risk of blood clots. Having alpelisib also increases the risk of blood clots such as a DVT (deep vein thrombosis).
If you have a DVT, there’s a risk part of the blood clot could break away and travel to the lung. This is known as a pulmonary embolism (PE).
Blood clots can be life-threatening and should be treated quickly.
Blood clot symptoms
Contact your treatment team or go to your local A&E department straight away if you have any of the following symptoms:
- Pain in your arm or leg
- Redness/discolouration of the skin of the arm or leg
- Heat and swelling of the arm or leg
- Swelling, redness or tenderness where a central line is inserted to give chemotherapy, for example in the arm, chest area or up into the neck
- Shortness of breath
- Pain or tightness in the chest
- Unexplained cough or coughing up blood
Find out more about blood clots.
Medicines to avoid when having alpelisib
You should not take certain drugs with alpelisib, including medicines for acid reflux or heartburn.
Tell your treatment team about any prescribed or over-the-counter medicines you’re taking.
Many people think about taking herbal products or supplements while having treatment for breast cancer. However, the exact effect and safety of taking these after a diagnosis of breast cancer is not fully understood. Ask your treatment team before taking any herbal products or supplements.
Sex and contraception
You can still have sex during treatment. It’s thought targeted therapy drugs cannot pass into vaginal fluids or semen, but this cannot be completely ruled out.
Most treatment teams will advise using barrier methods of contraception, such as condoms, during treatment and for at least 1 week after stopping treatment.
You’re advised not to become pregnant while having treatment because alpelisib can harm a developing baby. If you have not been through the menopause, talk to your team about the most suitable method of contraception for you. It’s still possible to become pregnant even if your periods are irregular or have stopped.
Men having alpelisib who have a partner who is pregnant or could become pregnant should use condoms during sex while taking alpelisib and for at least 1 week after the last dose.
Fertility
Alpelisib may affect fertility in both women and men.
If you were diagnosed with locally advanced or secondary breast cancer before you started or completed a family, you may be concerned about your fertility.
You can talk to your treatment team about any possible fertility preservation options before starting treatment.
Breastfeeding
You’re recommended not to breastfeed while having alpelisib and for at least a week after the last dose. This is because there’s a risk the drugs could be passed on through breast milk.
Travel and vaccinations
If you’re planning a holiday or need to travel overseas, check with your treatment team first.
You should not have any live vaccines while you’re having treatment.
For more information about vaccines, including COVID-19 and flu vaccines, see our information on vaccines and breast cancer.
7. Further support
Being diagnosed with secondary breast cancer can make you feel lonely and isolated.
Many people find it helps to talk to someone who has been through the same experience as them.
Our Living with Secondary Breast Cancer groups let you share experiences with other people dealing with the uncertainty and challenges of secondary breast cancer.
Find out more about our support services at the bottom of this page.
