What is Lynparza: How to use, Side Effects, Dosage

What is Lynparza: How to use, Side Effects, Dosage

What is Lynparza?

Olaparib is an inhibitor of the mammalian polyadenosine 5’-diphosphoribose polymerase (PARP) enzyme.

Olaparib is a crystalline solid, is non-chiral and shows pH-independent low solubility across the physiological pH range. Lynparza tablets for oral administration contain 100 mg or 150 mg of olaparib. Inactive ingredients in the tablet core are copovidone, mannitol, colloidal silicon dioxide and sodium stearyl fumarate. The tablet coating consists of hypromellose, polyethylene glycol 400, titanium dioxide, ferric oxide yellow and ferrosoferric oxide (150 mg tablet only).

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How to use Lynparza

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

The usual dose is eight capsules taken twice each day (a total of 16 capsules each day). You should not take any more or any less capsules unless your doctor tells you to. Your doctor may prescribe a different dose if you have problems with your kidneys, or are taking certain medicines that may interact with Lynparza capsules or if you experience certain side effects while you are taking Lynparza capsules.

Your doctor will tell you how many capsules of Lynparza to take and it is important that you take the total recommended daily dose.

How to take it

Swallow the capsules whole with a glass of water. Do not open the capsules.

Dosage of Lynparza

To avoid substitution errors and overdose, do not substitute Lynparza tablets with Lynparza capsules on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.

Recommended tablet dose is 300 mg taken orally twice daily with or without food.

Continue treatment until disease progression or unacceptable toxicity.

For adverse reactions, consider dose interruption or dose reduction.

For moderate renal impairment (CLcr 31-50 mL/min), reduce dose to 200 mg twice daily.

Over dosage

There is no specific treatment in the event of Lynparza overdose, and symptoms of overdose are not established. In the event of an overdose, physicians should follow general supportive measures and should treat the patient symptomatically.

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Side effects of Lynparza

Tell your doctor immediately if you notice any of the following:

feeling or being sick (nausea or vomiting)

dizziness, tiredness or weakness

indigestion or heartburn

loss of appetite

headache

change in taste of food (if it worries you)

diarrhea

sore mouth

cough

pain in the stomach area under the ribs

shortness of breath and/or a dry cough which can be due to inflammation of the lungs (pneumonitis).

rash, itchy swollen reddened skin

The above list includes serious side effects that may require medical attention and can be life-threatening, especially if not treated. If any of the following happen, tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

tightness of the chest, wheezing, coughing, shortness of breath or difficulty breathing.

swelling of the face, lips, tongue or other parts of the body.

severe skin reaction which may include rash, itching, redness, blistering or peeling of the skin.

These are very serious side effects. If you have them, you may have had a serious allergic reaction to Lynparza. You may need urgent medical attention or hospitalization. Some other serious side effects may only become known through tests. Your doctor will test your blood every month for the first year of treatment and periodically thereafter.

The blood tests may show:

a condition where there is damage to the blood-forming cells in your bone marrow (myelodysplastic syndrome/acute myeloid leukaemia)

decrease in the number of red blood cells (anemia) which can be associated with shortness of breath, fatigue, pale skin, or fast heart beat

decrease in white blood cells (neutropenia, leukopenia and lymphopenia), which can be associated with increased susceptibility to infection and/or symptoms of fever

increase in blood creatinine which can mean your kidneys are not working as well

decrease in the number of platelets (thrombocytopenia), which can result in bruising or bleeding for longer than normal if injured.

increase in the size of red blood cells (not associated with any symptoms).

Tell your doctor if you notice any of the symptoms above that may be because of changes in your blood.

These conditions may also be life-threatening, especially if not treated. Your doctor will tell you if your test results are abnormal and if you need treatment to correct for these side effects in your blood.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

Drugs that may interact with Lynparza

Anticancer Agents

Clinical studies of Lynparza in combination with other myelosuppressive anticancer agents, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.

Drugs That May Increase Olaparib Plasma Concentrations:

Olaparib is primarily metabolized by CYP3A. In patients (N=57), co-administration of itraconazole, a strong CYP3A inhibitor, increased AUC of olaparib by 170%. A moderate CYP3A inhibitor, fluconazole, is predicted to increase the AUC of olaparib by 121%.

Avoid concomitant use of strong CYP3A inhibitors such as itraconazole, telithromycin, clarithromycin, ketoconazole, voriconazole, nefazodone, posaconazole, ritonavir, lopinavir/ritonavir, indinavir, saquinavir, nelfinavir, boceprevir, and telaprevir. Avoid use of moderate CYPA inhibitors such as amprenavir, aprepitant, atazanavir, ciprofloxacin, crizotinib, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, and verapamil. If the strong or moderate CYP3A inhibitors must be co-administered, reduce the dose of Lynparza.

Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during Lynparza treatment since they are CYP3A inhibitors.

Drugs That May Decrease Olaparib Plasma Concentrations:

In patients (N=22), co-administration of rifampicin, a strong CYP3A inducer, decreased AUC of olaparib by 87%. A moderate CYP3A inducer, efavirenz, is predicted to decrease the AUC of olaparib by approximately 60%.

Avoid concomitant use of strong CYP3A inducers such as phenytoin, rifampicin, carbamazepine, and St. John’s Wort. Avoid concomitant use of moderate CYP3A4 inducers such as bosentan, efavirenz, etravirine, modafinil, and nafcillin. If a moderate CYP3A inducer cannot be avoided, there is a potential for decreased efficacy of Lynparza.

Warnings of Lynparza

Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in <1.5% of patients exposed to Lynparza monotherapy and the majority of events had a fatal outcome. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.

Pneumonitis: Occurred in <1% of patients exposed to Lynparza, and some cases were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.

Embryo-Fetal Toxicity: Lynparza can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

What is Lynparza

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