CAPIVAST 200 mg (Capivasertib): Uses, Dosage, Side Effects & Breast Cancer Treatment
CAPIVAST 200 mg (Capivasertib): Uses, Dosage, Side Effects & Breast Cancer Treatment
What Is CAPIVAST 200 mg?
CAPIVAST 200 mg contains capivasertib, an oral targeted anticancer medicine that belongs to the AKT inhibitor class.
Capivasertib blocks the activity of AKT proteins, which are important signalling molecules in the PI3K/AKT pathway. This pathway regulates several cellular processes, including cell growth, survival, metabolism and proliferation. In some breast cancers, abnormalities involving PIK3CA, AKT1 or PTEN can cause excessive pathway activity and contribute to cancer progression.
Current FDA and European regulatory information supports capivasertib in combination with fulvestrant for selected adults with hormone receptor-positive or oestrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more qualifying PIK3CA, AKT1 or PTEN alterations following progression or recurrence after endocrine-based therapy. Molecular testing is required to determine whether the tumour has an appropriate alteration.
The product details supplied for this article are:
Product Name: CAPIVAST 200 mg
Generic Name: Capivasertib
Strength: 200 mg
Dosage Form: Tablets
Pack Size: 64 Tablets
Capivasertib is a prescription oncology medicine and should be used only under the supervision of a healthcare professional experienced in cancer treatment.
What Is Capivasertib Used For?
Capivasertib is used as part of biomarker-directed treatment for certain types of advanced breast cancer.
HR-Positive, HER2-Negative Advanced Breast Cancer
In the United States, capivasertib is used with fulvestrant for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer whose tumours have one or more PIK3CA, AKT1 or PTEN alterations and whose disease has progressed after endocrine-based treatment.
ER-Positive, HER2-Negative Breast Cancer
European product information describes the indication as treatment with fulvestrant for adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer with qualifying PIK3CA, AKT1 or PTEN alterations after recurrence or progression on or after endocrine therapy.
Patient-Friendly Explanation
Some breast cancers depend on abnormal internal growth signals. Capivasertib blocks AKT proteins involved in one of these signalling pathways.
The medicine is not intended for every person with breast cancer. Tumour testing is needed to identify whether the cancer has a relevant PIK3CA, AKT1 or PTEN alteration.
Medical Explanation
Capivasertib is an inhibitor of the serine/threonine kinases AKT1, AKT2 and AKT3. Inhibition of these kinases reduces downstream signalling within the PI3K/AKT pathway and can limit proliferation and survival signalling in susceptible tumour cells.
How Does Capivasertib Work?
Capivasertib targets the AKT signalling pathway, a central component of cellular growth and survival biology.
AKT proteins are serine/threonine kinases that function downstream of PI3K. Under normal circumstances, the PI3K/AKT pathway helps control cellular metabolism, growth, proliferation, survival and movement.
In certain cancers, this pathway becomes abnormally activated.
Relevant genetic abnormalities may include:
- PIK3CA alterations
- AKT1 alterations
- PTEN loss or alterations
These changes can increase signalling through the pathway and promote tumour-cell survival.
A simplified pathway is:
PIK3CA / AKT1 / PTEN alteration → increased AKT signalling → tumour growth and survival
Capivasertib interrupts this pathway:
Capivasertib → AKT1/AKT2/AKT3 inhibition → reduced downstream signalling → reduced proliferation and survival signalling
The medicine therefore represents a form of precision oncology because it is used in patients whose tumour biology suggests that the AKT pathway is clinically relevant.
Capivasertib is normally given with fulvestrant, an endocrine therapy. The treatment approach therefore targets breast cancer through two different mechanisms: hormonal signalling through fulvestrant and intracellular AKT signalling through capivasertib.
This combination does not guarantee that cancer will disappear completely. The therapeutic aim is to control disease and delay progression in appropriate patients.
Key Indications
Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
Capivasertib may be prescribed for eligible adults whose breast cancer is:
- Hormone receptor-positive
- HER2-negative
- Locally advanced or metastatic
- Associated with a qualifying PIK3CA, AKT1 or PTEN alteration
- Previously treated with an endocrine-based regimen
Biomarker-Selected Breast Cancer
Capivasertib is a biomarker-directed treatment. Testing for PIK3CA, AKT1 and PTEN abnormalities plays an important role in determining treatment suitability.
CAPIVAST 200 mg Dosage & Administration
The current FDA-recommended capivasertib regimen is:
400 mg orally twice daily, approximately 12 hours apart, for 4 consecutive days followed by 3 days without capivasertib each week.
With a 200 mg tablet strength, a 400 mg dose corresponds to two 200 mg tablets per scheduled dose.
Capivasertib is used in combination with fulvestrant.
How to Take Capivasertib
- Take capivasertib exactly as prescribed.
- Take the morning and evening doses approximately 12 hours apart.
- Follow the 4-days-on / 3-days-off weekly schedule.
- It may be taken with or without food.
- Do not independently change the dose.
- Dose interruption or reduction may be necessary if adverse reactions occur.
Missed Dose
If a dose is missed, current FDA instructions allow it to be taken within 4 hours of the usual scheduled time. If more than 4 hours have passed, the dose should be skipped and the next dose taken at its normal time.
Vomiting After a Dose
If vomiting occurs after taking capivasertib, another dose should not automatically be taken. The next dose should be taken at the usual scheduled time.
Capivasertib Side Effects
Capivasertib can cause adverse reactions, and patients require appropriate clinical monitoring.
Common Side Effects
Commonly reported reactions and laboratory abnormalities include:
- Diarrhea
- Skin reactions or rash
- Increased blood glucose
- Fatigue
- Nausea
- Mouth inflammation or stomatitis
- Vomiting
- Reduced haemoglobin
- Reduced lymphocyte count
- Reduced white blood-cell count
- Increased triglycerides
- Reduced neutrophil count
In the pivotal trial population, diarrhea, elevated glucose and cutaneous reactions were among the most frequently reported effects.
Less Common Side Effects
Clinically relevant effects can include:
- Anaemia
- Fever
- Altered taste
- Indigestion
- Pneumonia
- Weight loss
- Hypersensitivity reactions
Serious Side Effects
Important serious risks include:
- Severe hyperglycemia
- Diabetic ketoacidosis
- Severe diarrhea
- Serious skin reactions
- Severe hypersensitivity
- Pneumonia
- Kidney injury
The FDA specifically highlights hyperglycemia, diarrhea and cutaneous adverse reactions as major warnings.
When to Seek Medical Attention
Prompt medical assessment is important for:
- Extreme thirst or frequent urination
- Confusion or marked weakness
- Severe or persistent diarrhea
- Extensive rash
- Blistering or peeling skin
- Fever with rash
- Difficulty breathing
- Severe allergic symptoms
- Signs of dehydration
Hyperglycemia and Blood Sugar Monitoring
One of the most important safety considerations with capivasertib is hyperglycemia.
Severe elevations in blood glucose, including diabetic ketoacidosis, can occur. The FDA recommends evaluating fasting blood glucose and HbA1c before starting treatment and monitoring them regularly during therapy.
Patients with diabetes or pre-existing abnormal glucose levels should make sure their oncology team knows about their condition before treatment.
Symptoms of high blood sugar may include:
- Increased thirst
- Frequent urination
- Increased hunger
- Weakness
- Blurred vision
- Confusion in severe cases
Diarrhea Risk
Diarrhea is one of the most frequent adverse reactions associated with capivasertib.
Patients should inform their healthcare professional promptly if diarrhea develops. Management may include fluid replacement, antidiarrheal medicines, treatment interruption or dose reduction depending on severity.
Skin Reactions
Capivasertib can cause cutaneous adverse reactions ranging from mild rash to more serious skin toxicity.
Patients should report:
- New rash
- Worsening rash
- Redness
- Peeling
- Blistering
- Skin pain
Early medical evaluation is important if significant skin symptoms develop.
Drug Interactions
Capivasertib is metabolized partly through CYP3A, so medicines that strongly affect this pathway can alter capivasertib exposure.
Medicines to Avoid or Review
Current FDA prescribing information recommends particular caution with:
- Strong CYP3A inhibitors
- Moderate CYP3A inhibitors
- Strong CYP3A inducers
- Moderate CYP3A inducers
Strong CYP3A inhibitors should generally be avoided where possible; dose reduction may be required if unavoidable. Moderate inhibitors can also require dose modification, while strong and moderate CYP3A inducers should generally be avoided.
Food Considerations
Capivasertib may be taken with or without food.
However, grapefruit products should be avoided because they may interact with capivasertib.
Supplement Considerations
Patients should tell their healthcare professional about:
- St John's wort
- Herbal medicines
- Traditional medicines
- Vitamins
- High-dose supplements
- Unregulated cancer supplements
Pregnancy & Breastfeeding
Capivasertib can cause fetal harm based on its mechanism of action and animal reproductive studies.
Females of reproductive potential should discuss effective contraception with their healthcare provider. Current FDA labeling recommends contraception during treatment and for 1 month after the final dose for females of reproductive potential.
Breastfeeding is not recommended during capivasertib treatment according to current U.S. prescribing information.
Special Populations
Elderly Patients
Older adults may receive capivasertib when clinically appropriate. Treatment should consider overall health, concurrent medicines, glucose control and treatment tolerance.
Pediatric Patients
Safety and effectiveness have not been established for routine pediatric use under the current U.S. indication.
Renal Impairment
Patients with kidney impairment should inform the treating physician before therapy. Renal function and overall clinical status may influence monitoring decisions.
Hepatic Impairment
Patients with liver impairment should be evaluated according to the applicable prescribing information and oncology treatment plan.
Storage
Store CAPIVAST according to the storage instructions provided on the product packaging.
General precautions include:
- Keep tablets in their original container or packaging.
- Protect from unsuitable heat and moisture.
- Keep out of reach of children.
- Do not use damaged tablets.
- Do not use the medicine after the labelled expiry date.
- Follow the product-specific temperature instructions.
Frequently Asked Questions
1. What is CAPIVAST 200 mg used for?
CAPIVAST contains capivasertib, an AKT inhibitor used with fulvestrant for selected adults with HR-positive, HER2-negative advanced or metastatic breast cancer with qualifying PIK3CA, AKT1 or PTEN alterations.
2. What is Capivasertib?
Capivasertib is an oral targeted anticancer medicine that inhibits AKT1, AKT2 and AKT3.
3. Is Capivasertib chemotherapy?
Capivasertib is generally classified as targeted therapy rather than conventional cytotoxic chemotherapy.
4. How does Capivasertib work?
It blocks AKT proteins in the PI3K/AKT signalling pathway, which can reduce cancer-cell growth and survival signalling.
5. What cancers is Capivasertib used for?
Its established regulatory use is in selected biomarker-positive HR/ER-positive, HER2-negative locally advanced or metastatic breast cancer.
6. What is the usual Capivasertib dose?
The recommended regimen is 400 mg twice daily for 4 days, followed by 3 days off treatment each week.
7. Can Capivasertib be taken with food?
Yes. It may be taken with or without food.
8. What are common Capivasertib side effects?
Common effects include diarrhea, skin reactions, increased blood glucose, fatigue, nausea, stomatitis and vomiting.
9. Can Capivasertib raise blood sugar?
Yes. Hyperglycemia is an important safety risk and blood glucose monitoring is required.
10. Does Capivasertib cause diarrhea?
Yes. Diarrhea is one of the most frequently reported adverse reactions.
11. Can Capivasertib cause skin rash?
Yes. Skin reactions are common and occasionally serious, so new or worsening rash should be reported promptly.
12. Why is genetic testing needed before Capivasertib?
The treatment is intended for patients whose tumours have qualifying PIK3CA, AKT1 or PTEN alterations.
13. Is Capivasertib used alone?
For its approved breast cancer indication, capivasertib is used in combination with fulvestrant.
14. Can grapefruit be taken with Capivasertib?
Current FDA patient information advises avoiding grapefruit products because of potential interaction.
15. What should I do if I miss a Capivasertib dose?
A missed dose may be taken within 4 hours of the usual time. After that, skip it and take the next scheduled dose normally.
Global Medicine Information & Support by RootAid Pharma
RootAid Pharma provides educational medicine information and specialty pharmaceutical support for people and organizations seeking information about prescription and high-value medicines.
Our resources cover areas including oncology medicines, targeted therapies, breast cancer treatment information, medicine safety, dosing information, drug interactions and international specialty-medicine support.
For biomarker-directed medicines such as capivasertib, appropriate molecular testing and specialist oncology assessment are essential before treatment.
RootAid Pharma does not claim to manufacture CAPIVAST or capivasertib. Product availability, prescription requirements, import regulations and supply conditions may vary between countries.
Medical Disclaimer
This article is intended for educational and informational purposes only and does not replace medical diagnosis, official prescribing information or individualized advice from an oncologist, physician or pharmacist.
Capivasertib is a prescription anticancer medicine intended for selected patients with specific clinical and molecular characteristics. Biomarker testing, dosing, combination therapy, monitoring, treatment duration and management of adverse reactions must be determined by the treating healthcare professional.
Approved indications and prescribing recommendations may vary by country and can change over time. Patients should always follow the official product information applicable to their location.
Do not start, stop or alter capivasertib treatment without professional medical advice.
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