Filastin Side effects

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

What are the possible side effects of Filastin?

Get emergency medical help if you have signs of an allergic reaction to Filastin: hives, sweating; dizziness, fast heart rate; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Filastin can cause your spleen to become enlarged and it could rupture (tear). Call your doctor right away if you have sudden or severe pain in your left upper stomach spreading up to your shoulder.

Stop using Filastin and call your doctor at once if you have:

• rapid breathing or feeling short of breath;

• capillary leak syndrome--sudden dizziness or light-headed feeling, tiredness, trouble breathing, swelling or puffiness and feeling full;

• kidney problems--little or no urinating, blood in your urine, swelling in your face or ankles; or

• signs of infection--fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness.

Common Filastin side effects may include:

• fever, cough, trouble breathing;

• nosebleeds;

• bone pain, muscle or joint pain;

• diarrhea;

• headache;

• numbness; or

• rash, thinning hair.

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 Filastin in details

During clinical studies 183 cancer patients and 96 healthy volunteers were exposed to Filastin.

The safety profile of Filastin observed in these clinical studies was consistent with that reported with the reference product used in these studies.

The following undesirable effects and their frequencies have been observed under treatment with Filastin based on published information.

The assessment of undesirable effects is based on the following frequency data: Very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000; not known: cannot be estimated from the available data.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

In Cancer Patients: In clinical trials, the most frequent undesirable effects attributable to Filastin at the recommended dose were mild or moderate musculoskeletal pain, occurring in 10%, and severe musculoskeletal pain in 3% of patients. Musculoskeletal pain is usually controlled with standard analgesics. Less frequent undesirable effects include urinary abnormalities predominantly mild or moderate dysuria.

In randomised, placebo-controlled clinical trials, Filastin did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy. Undesirable effects reported with equal frequency in patients treated with Filastin chemotherapy and placebo/chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and unspecified pain.

Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase, alkaline phosphatase, serum uric acid, and gamma-glutamyl transpeptidase occurred with Filastin in approximately 50%, 35%, 25%, and 10% of patients, respectively at recommended doses.

Transient decreases in blood pressure, not requiring clinical treatment, have been reported occasionally.

There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation.

Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation. The causal association with Filastin has not been established.

Very rare events of cutaneous vasculitis have been reported in patients treated with Filastin. The mechanism of vasculitis in patients receiving Filastin is unknown.

Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use. These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis. Capillary Leak Syndrome, which can be life-threatening if treatment is delayed, has been reported uncommonly (≥1/1,000 to <1/100) in cancer patients undergoing chemotherapy following administration of granulocyte colony-stimulating factors.

The occurrence of Sweet's syndrome (acute febrile dermatosis) has been reported occasionally. However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with Filastin has not been established.

Exacerbation of rheumatoid arthritis has been observed in individual cases.

Rare pulmonary adverse events including interstitial pneumonia, pulmonary oedema, and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS), which may be fatal.

Allergic Reactions: Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea and hypotension, occurring on initial or subsequent treatment have been reported in patients receiving Filastin. Overall, reports were more common after intravenous administration. In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.

Filastin should be permanently discontinued in patients who experience a serious allergic reaction.

Isolated cases of sickle cells crises have been reported in patients with sickle cell disease.

Pseudogout has been reported in patients with cancer treated with Filastin.

In Peripheral Blood Progenitor Cell Mobilisation in Normal Donors: The most commonly reported undesirable effect was mild to moderate transient musculo-skeletal pain. Leukocytosis [White Blood Cell (WBC) >50 x 10⁹/L] was observed in 41% of donors and transient thrombocytopenia (platelets <100 x 10⁹/L) following Filastin and leukapheresis was observed in 35% of donors.

Transient, minor increases in alkaline phosphatase, LDH, SGOT and uric acid have been reported in normal donors receiving Filastin; these were without clinical sequelae.

Exacerbation of arthritic symptoms has been observed very rarely.

Symptoms suggestive of severe allergic reactions have been reported very rarely.

Headaches, believed to be caused by Filastin, have been reported in PBPC donor studies.

Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs.

In normal donors, pulmonary adverse events (haemoptysis, pulmonary haemorrhage, pulmonary infiltrates, dyspnoea and hypoxia) have been reported very rarely in post marketing experience with other Filastin-containing medicinal products.

In Severe Chronic Neutropenia (SCN) Patients: Undesirable effects related to Filastin therapy in SCN patients have been reported and for some their frequency tend to decrease with time.

The most frequent undesirable effects attributable to Filastin were bone pain, and general musculoskeletal pain.

Other undesirable effects seen include splenic enlargement, which may be progressive in a minority of cases and thrombocytopenia. Headache and diarrhoea have been reported shortly after starting Filastin therapy, typically in less than 10% of patients. Anaemia and epistaxis have also been reported.

Transient increases with no clinical symptoms were observed in serum uric acid, lactic dehydrogenase, and alkaline phosphatase. Transient, moderate decreases in non-fasting blood glucose have also been seen.

Undesirable effects possibly related to Filastin therapy and typically occurring in <2% of SCN patients were injection site reaction, headache, hepatomegaly, arthralgia, alopecia, osteoporosis, and rash.

During long term use cutaneous vasculitis has been reported in 2% of SCN patients. There have been very few instances of proteinuria/haematuria.

In Patients with HIV: In clinical studies, the only undesirable effects that were consistently considered to be related to Filastin administration were musculoskeletal pain, predominantly mild to moderate bone pain and myalgia. The incidence of these events was similar to that reported in cancer patients.

Splenic enlargement was reported to be related to Filastin therapy in <3% of patients. In all cases this was mild or moderate on physical examination and the clinical course was benign; no patients had a diagnosis of hypersplenism and no patients underwent splenectomy. As splenic enlargement is a common finding in patients with HIV infection and is present to varying degrees in most patients with AIDS, the relationship to Filastin treatment is unclear.

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

• Filastin may cause an allergic reaction (rash; hives; itching; swelling of the mouth, face, lips, or tongue; dizziness; fainting; shortness of breath; wheezing; fast heartbeat; sudden increased sweating), usually within 30 minutes after receiving this medication. Contact your doctor immediately if you experience an allergic reaction.
• Filastin may not prevent all infections. Contact your doctor right away if you develop signs of an infection (eg, fever; chills; rash; sore throat; diarrhea; pain, redness, or swelling around a cut or sore).
• You may experience bone or muscle aches while you use Filastin. These symptoms can usually be relieved by a non-aspirin pain reliever (eg, acetaminophen).
• Serious and sometimes fatal spleen problems (including spleen rupture) have been reported in patients using Filastin. Contact your doctor right away if pain occurs in the left upper stomach area or left shoulder tip area.
• Filastin may interfere with certain lab tests, including bone-imaging. Be sure your doctor and lab personnel know you are taking Filastin.
• Lab tests, including complete blood cell counts, may be performed while you use Filastin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Filastin while you are pregnant. It is not known if Filastin is found in breast milk. If you are or will be breast-feeding while you use Filastin, check with your doctor. Discuss any possible risks to your baby.

Filastin contraindications

You should not use this medication if you are allergic to Filastin or to other medicines that contain the E. coli bacteria.

Before using Filastin, tell your doctor if you have a blood cell disorder (such as sickle cell anemia), chronic myeloid leukemia, myelodysplasia (also called "preleukemia"), or if you are receiving chemotherapy or radiation treatment.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.

To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with Filastin. Your liver function will also need to be tested, and you may need bone density scans. Visit your doctor regularly.

Stop using Filastin and call your doctor at once if you have a serious side effect such as sudden or severe pain in your left upper stomach spreading up to your shoulder, rapid breathing or feeling short of breath, or signs of infection (fever, chills, sore throat, flu symptoms, easy bruising or bleeding, loss of appetite, nausea and vomiting, mouth sores, or unusual weakness).

Reviews

The results of a survey conducted on ndrugs.com for Filastin 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 Filastin. 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