Talzenna

Generic name: talazoparib
Drug class: PARP inhibitors

Medically reviewed by  A Ras MD

What is Talzenna?

Talzenna  is a prescription medication that is used for the treatment of breast cancer

Description

Talazoparib is an inhibitor of mammalian polyadenosine 5′-diphosphoribose polymerase (PARP) enzyme. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below:

Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as:

• 0.25 mg hard hypromellose (HPMC) capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or
• 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or
• 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or
• 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.

Inactive ingredients: silicified microcrystalline cellulose (sMCC). The capsule shells contain HPMC, yellow iron oxide, red iron oxide and titanium dioxide; and the printing ink contains shellac, black iron oxide, potassium hydroxide, ammonium hydroxide, and propylene glycol.

Mechanism of Action

Talazoparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play a role in DNA repair. In vitro studies with cancer cell lines that harbored defects in DNA repair genes, including BRCA 1 and BRCA 2, have shown that talazoparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, decreased cell proliferation, and apoptosis. Talazoparib anti-tumor activity was observed in human patient-derived xenograft breast cancer tumor models bearing mutated BRCA 1 or mutated BRCA 2 or wild-type BRCA 1 and BRCA 2.

Before taking Talzenna, tell your doctor:

• If you are allergic to Talzenna; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have had chemo treatments before and you still have blood problems from those treatments.
• If you are breast-feeding. Do not breast-feed while you take Talzenna or for 1 month after you stop Talzenna.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Talzenna with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Talzenna?

• Tell all of your health care providers that you take Talzenna. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Rarely, a bone marrow problem called myelodysplastic syndrome (MDS) has happened in patients treated with Talzenna. A type of leukemia has also rarely happened. If you have questions, talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• This medicine may affect being able to father a child. Talk with the doctor.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start Talzenna to show that you are NOT pregnant.
• Women must use birth control while taking Talzenna and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Men with a partner who may get pregnant must use birth control while taking Talzenna and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.

How is Talzenna best taken?

Use Talzenna as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Swallow whole. Do not chew, break, open, or dissolve.
• Keep taking Talzenna as you have been told by your doctor or other health care provider, even if you feel well.
• If you throw up after taking a dose, do not repeat the dose. Take your next dose at your normal time.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Talzenna that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Weight loss.
• Shortness of breath.

What are some other side effects of Talzenna?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hair loss.
• Headache.
• Feeling dizzy, sleepy, tired, or weak.
• Stomach pain.
• Change in taste.
• Mouth irritation or mouth sores.
• Diarrhea, throwing up, upset stomach, and feeling less hungry are common with Talzenna. If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not get better, or get very bad.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Talzenna?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 0.25 MG CAPSULE BOTTLE LABEL

• Pfizer
• NDC 0069-0296-30
• Talzenna®
  (talazoparib) capsules
• 0.25 mg
• 30 Capsules
  Rx only

SRC: NLM .