Arinib Side effects

• Side effects of Arinib in details
• Arinib contraindications
• Arinib reviews

What are the possible side effects of Arinib?

Get emergency medical help if you have any signs of an allergic reaction to Arinib: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• a bone fracture;

• swollen glands;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Arinib side effects may include:

• weakness, hot flashes;

• numbness or tingly feeling in your skin;

• swelling in your ankles or feet;

• joint pain or stiffness, problems with your fingers while gripping;

• sore throat, headache, back pain, bone pain;

• depression, mood changes, sleep problems (insomnia);

• high blood pressure (severe headache, blurred vision, pounding in your neck or ears);

• nausea, vomiting; or

• mild rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Arinib in details

Unless specified, the following frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer treated for 5 years (ATAC Study).

The table below presents the frequency of pre-specified adverse events in the ATAC study, irrespective of causality, reported in patients receiving trial therapy and up to 14 days after cessation of trial therapy.

The ATAC trial data showed that patients receiving Arinib had an increase in joint disorders (including arthritis, arthrosis, and arthralgia) compared with patients receiving tamoxifen. Patients receiving Arinib had an increase in the incidence of fractures (including fractures of spine, hip and wrist) compared with patients receiving tamoxifen. These differences were statistically significant. Fracture rates of 22 per 1,000 patient-years and 15 per 1000 patient-years were observed for the Arinib and tamoxifen groups, respectively, after a median follow up of 68 months. The observed fracture rate for Arinib is similar to the range reported in age-matched postmenopausal populations. It has not been determined whether the rates of fracture and osteoporosis seen in ATAC in patients on Arinib treatment reflect a protective effect of tamoxifen, a specific effect of Arinib, or both.

The incidence of osteoporosis was 10.5% in patients treated with Arinib and 7.3% in patients treated with tamoxifen.

Patients receiving Arinib had a decrease in hot flushes, vaginal bleeding, vaginal discharge, endometrial cancer, venous thromboembolic events (including deep venous thrombosis) and ischaemic cerebrovascular events compared with patients receiving tamoxifen. These differences were statistically significant.

Results from the ATAC trial bone substudy, at 12 and 24 months demonstrated that patients receiving Arinib had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline.

Slight increases in total cholesterol have also been observed in clinical trials with Arinib, although the clinical significance has not been determined.

What is the most important information I should know about Arinib?

• Arinib may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Arinib with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Arinib lowers the amount of estrogen in your body, which may cause your bones to become softer and weaker. This may increase your chance of bone fractures, especially of the spine, hip, and wrist. Discuss any questions or concerns with your doctor.
• Women who have a history of blockage in the heart arteries (ischemic heart disease) may have an increase in symptoms of decreased blood flow to the heart. Call your doctor right away if you have new or worsening chest pain or shortness of breath while taking Arinib. Discuss any questions or concerns with your doctor.
• Lab tests, including blood cholesterol, bone mineral density, or liver function, may be performed while you use Arinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Arinib should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Arinib if you are pregnant. It has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. It is not known if Arinib is found in breast milk. Do not breast-feed while taking Arinib.

Arinib contraindications

Do not use Arinib if you are pregnant. It could harm the unborn baby.

You may need to take a pregnancy test before using Arinib, to make sure you are not pregnant.

You should not use this medication if you are allergic to Arinib, if you are breast-feeding a baby, or if you have not yet completed menopause. Arinib is not for use in men or children.

Before using Arinib, tell your doctor if you have heart disease, circulation problems, a history of stroke or blood clot, severe liver disease, high cholesterol, osteoporosis, or low bone mineral density.

Arinib may not work as well if you take it together with tamoxifen or an estrogen medication (such as hormone replacement therapy, estrogen creams, or birth control pills, injections, implants, skin patches, and vaginal rings). Before you start taking Arinib, tell your doctor if you also take tamoxifen or estrogen.

You may need to keep taking Arinib for up to 5 years. Follow your doctor's instructions.

References

1. DailyMed. "ANASTROZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "anastrozole: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. ".alpha.1,.alpha.1,.alpha.3,.alpha.3-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetonitrile: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Arinib are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Arinib. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology