What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Akeega (Abiraterone/Niraparib)
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Product Details
Description
Akeega combines two potent drugs, niraparib and abiraterone acetate, forming a tablet designed to treat prostate cancer. Niraparib belongs to the class of medications known as PARP inhibitors and assists in preventing cancer cells from repairing themselves, ultimately leading to their death. Abiraterone acetate, on the other hand, classifies as a CYP17 inhibitor and works to reduce the amount of certain hormones, including testosterone, thus starving the prostate cancer cells of the hormones they need to grow. Patients use Akeega with prednisone to treat metastatic castration-resistant prostate cancer (mCRPC) specifically when they test positive for mutations in the BRCA genes.
Fact Table
Formula
Abiraterone: C26H33NO2, Niraparib: C19H20N4O
License
FDA approved
Bioavailability
Abiraterone: ~50% (fasting), Niraparib: 73%
Legal status
Rx-Only
Chemical Name
Abiraterone/Niraparib
Elimination half-life
Abiraterone: 12 to 24 hours, Niraparib: 36 hours
Dosage (Strength)
500 / 50mg, 500 / 100mg
Pregnancy
Consult Doctor
Brands
Akeega
Protein binding
Unknown
PubChem CID
Abiraterone: 132971, Niraparib: 24958200
MedlinePlus
Abiraterone: a611043
ChEBI
Abiraterone: CHEBI:68639
ATC code
Abiraterone: L02BX03
DrugBank
Abiraterone: DB05812
KEGG
Abiraterone: D09359
Routes of administration
Oral (both)
Directions
Akeega is typically taken orally once a day. Patients should swallow the tablet whole, without crushing or breaking it, and take it with water. It’s usually recommended to consume Akeega on an empty stomach; avoid eating at least two hours before and one hour after ingesting the tablet. Be mindful of the timing and consistency each day to maintain steady levels of medication in your body.
Ingredients
Akeega contains the two active ingredients niraparib tosylate monohydrate and abiraterone acetate.
Contraindications
There are no known contraindications on the FDA label. However, you should avoid taking or using Akeega if you have a known hypersensitivity to niraparib, abiraterone acetate, or any component of the product.
Cautions
- Before starting Akeega, inform your doctor if any of the following apply:
- Other medications being taken, including over-the-counter drugs and herbal supplements
- Other medical conditions
- Current partner’s pregnancy or breastfeeding, or future plans of doing so
- Any allergies to medication ingredients
- Akeega has been linked to serious blood disorders, including myelodysplastic syndrome and acute myeloid leukemia. These conditions can be life-threatening. Regular blood tests are crucial to monitor for these risks. If these disorders are diagnosed, Akeega treatment should be stopped.
- Akeega can affect your blood cell counts. It’s important to have your blood counts checked weekly for the first month, every two weeks for the next two months, monthly for the rest of the year, and then every other month or as your doctor advises.
- Akeega may cause increases in blood pressure, low potassium levels, and fluid retention. Monitoring for these conditions should be frequent, especially in the first two months of treatment. People with existing heart conditions should be extra cautious.
- Liver damage, which can be severe and potentially fatal, has been reported in patients taking Akeega. Regular liver function tests are recommended, and adjustments to treatment may be necessary based on these results.
- Akeega can impact the adrenal glands, which produce important hormones. Watch for symptoms of adrenal insufficiency and stress may require an adjustment in your medication.
- If you are taking diabetes medications, especially certain types like thiazolidinediones or repaglinide, Akeega can cause dangerously low blood sugar levels. It’s important to monitor your blood sugar more closely if you have diabetes.
- Using Akeega with certain other treatments, like radium Ra 223 dichloride, is not recommended due to an increased risk of fractures and death.
- There have been cases of a condition called posterior reversible encephalopathy syndrome in patients taking Akeega. If this condition is diagnosed, stop using Akeega.
- Akeega can harm an unborn baby. It is crucial for men with partners who could become pregnant to use effective contraception during treatment.
Side Effects
Akeega can cause a range of side effects, though not everyone will experience them. The most common include muscle and bone pain, swelling in legs or feet, bleeding, tiredness, shortness of breath, urinary tract infections, changes in liver function, decreased appetite, cough, constipation, vomiting, trouble sleeping, high blood pressure, dizziness, changes in weight, nausea, and symptoms related to COVID-19.
Some adverse reactions to Akeega may be more severe and require immediate medical attention. These include low blood potassium levels, fluid retention, high blood pressure, heart problems, and severe liver issues, such as liver failure indicated by yellowing of the skin or eyes and dark urine. Adrenal problems, low blood sugar (especially in people with diabetes), increased risk of bone fractures, and a brain condition called posterior reversible encephalopathy syndrome are also serious concerns. If any of these severe side effects occur, contact a healthcare provider promptly.
References:
- Akeega (Abiraterone/Niraparib) Product Monograph. Horsham, PA: Janssen Biotech; 2023.
- Akeega (Abiraterone/Niraparib) Drug Label Information. Horsham, PA: Janssen Biotech; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14541
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