52.72.178.215 (EC2-52-72-178-215.COMPUTE-1.AMAZONAWS.COM)
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abraxane.com
Learn about ABRAXANE®, including benefits & risks, possible side effects, patient support, and options for financial help.
pomalyst.com
POMALYST is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least 2 prior therapies and have demonstrated disease progression. Please see the full Indication and Important Safety Information for POMALYST. Indication POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. Important Safety Information WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment. POMALYST is only available through a restricted distribution program called POMALYST REMS®. Venous and Arterial Thromboembolism Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors. CONTRAINDICATIONS Pregnancy: POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If POMALYST is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity & Females of Reproductive Potential: See Boxed WARNINGS – Males: Pomalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Males must not donate sperm. – Blood Donation: Patients must not donate blood during treatment with POMALYST and for 1 month following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST. POMALYST REMS® Program: See Boxed WARNINGS – Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive POMALYST. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements. – Further information about the POMALYST REMS program is available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436. Venous and Arterial Thromboembolism: See Boxed WARNINGS. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors. Hematologic Toxicity: Neutropenia (46%) was the most frequently reported Grade 3/4 adverse reaction in patients taking POMALYST in clinical trials, followed by anemia and thrombocytopenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification. Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered. Hypersensitivity Reactions: Angioedema and severe dermatologic reactions have been reported. Discontinue POMALYST for angioedema, skin exfoliation, bullae, or any other severe dermatologic reactions, and do not resume therapy. Dizziness and Confusional State: In patients taking POMALYST in clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7% a confusional state (3% Grade 3 or 4). Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice. Neuropathy: In patients taking POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3 in one trial) and 12% peripheral neuropathy. Second Primary Malignancies: Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of multiple myeloma. Tumor Lysis Syndrome (TLS): TLS may occur in patients treated with POMALYST. Patients at risk are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken. ADVERSE REACTIONS Nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). The most common adverse reactions included neutropenia (51.3%), fatigue and asthenia (46.7%), upper respiratory tract infection (31%), thrombocytopenia (29.7%), pyrexia (26.7%), dyspnea (25.3%), diarrhea (22%), constipation (21.7%), back pain (19.7%), cough (20%), pneumonia (19.3%), bone pain (18%), edema peripheral (17.3%), peripheral neuropathy (17.3%), muscle spasms (15.3%), and nausea (15%). Grade 3 or 4 adverse reactions included neutropenia (48.3%), thrombocytopenia (22%), and pneumonia (15.7%). DRUG INTERACTIONS Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. Consider alternative treatments. If a strong CYP1A2 inhibitor must be used, reduce POMALYST dose by 50%. USE IN SPECIFIC POPULATIONS Pregnancy: See Boxed WARNINGS. If pregnancy does occur during treatment, immediately discontinue the drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. There is a POMALYST pregnancy exposure registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy as well as female partners of male patients who are exposed to POMALYST. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436. Lactation: There is no information regarding the presence of pomalidomide in human milk, the effects of POMALYST on the breastfed infant, or the effects of POMALYST on milk production. Pomalidomide was excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from POMALYST, advise a nursing woman to discontinue breastfeeding during treatment with POMALYST. Pediatric Use: Safety and effectiveness have not been established in pediatric patients. Geriatric Use: No dosage adjustment is required for POMALYST based on age. Patients >65 years of age were more likely than patients ≤65 years of age to experience pneumonia. Renal Impairment: Reduce POMALYST dose by 25% in patients with severe renal impairment requiring dialysis. Take dose of POMALYST following hemodialysis on hemodialysis days. Hepatic Impairment: Reduce POMALYST dose by 25% in patients with mild to moderate hepatic impairment and 50% in patients with severe hepatic impairment. Smoking Tobacco: Advise patients that smoking may reduce the efficacy of POMALYST. Cigarette smoking reduces the AUC of pomalidomide by 32% by CYP1A2 induction. Please see full Prescribing Information, including Boxed WARNINGS.
revlimid.com
About REVLIMID® (lenalidomide) treatment for deletion 5q myelodysplastic syndromes, mantle cell lymphoma and multiple myeloma including full indications, dosing, administration, efficacy, safety & prescribing information. Indication REVLIMID® (lenalidomide) is used with dexamethasone to treat patients with multiple myeloma (MM) REVLIMID® is used to treat patients who have low- or intermediate-1–risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions REVLIMID® is used to treat patients with mantle cell lymphoma (MCL) when the disease comes back or becomes worse after treatment with two prior medicines, one of which included bortezomib REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial It is not known if REVLIMID is safe and effective in children under 18 years of age Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide TO REPORT SUSPECTED ADVERSE REACTIONS OR EMBRYO-FETAL EXPOSURE: CONTACT CELGENE CORPORATION AT 1-888-423-5436 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH Important Safety Information + What is the most important information I should know about REVLIMID? Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS® program. Before prescribing REVLIMID, your healthcare provider will explain the REVLIMID REMS program to you and have you sign the Patient-Physician Agreement Form. REVLIMID may cause serious side effects, including: Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID. REVLIMID is similar to the medicine thalidomide (THALOMID®), which is known to cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing. Females must not get pregnant: For at least 4 weeks before starting REVLIMID While taking REVLIMID During any breaks (interruptions) in your treatment with REVLIMID For at least 4 weeks after stopping REVLIMID Females who can become pregnant: Must have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling. Must agree to use 2 different forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID. Talk with your healthcare provider to find out about options for effective forms of birth control that you may use to prevent pregnancy. If you had unprotected sex or if you think your birth control has failed, stop taking REVLIMID immediately and call your healthcare provider right away. If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call Celgene Customer Care Center at 1-888-423-5436. Healthcare providers and patients should report all cases of pregnancy to FDA MedWatch at 1-800-FDA-1088, and Celgene Corporation at 1-888-423-5436. There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID during pregnancy, or if their male partner takes REVLIMID and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above. REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for up to 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, you should call your HCP right away. The baby may be exposed to REVLIMID and may be born with birth defects. Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant. Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising, during treatment with REVLIMID. Blood clots. Blood clots in the arteries, veins, and lungs happen more often in people who take REVLIMID. This risk is even higher for people with multiple myeloma who take the medicine dexamethasone with REVLIMID. Heart attacks and strokes also happen more often in people who take REVLIMID with dexamethasone. To reduce this increased risk, most people who take REVLIMID will also take a blood thinner medicine. Before taking REVLIMID, tell your healthcare provider: If you have had a blood clot in the past If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia) About all the medicines you take. Certain other medicines can also increase your risk for blood clots Call your healthcare provider or get medical help right away if you get any of the following during treatment with REVLIMID: Signs or symptoms of a blood clot in the lung, arm, or leg may include: shortness of breath, chest pain, or arm or leg swelling Signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick or vomiting Signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance Who should not take REVLIMID? Do not take REVLIMID if you are pregnant, plan to become pregnant, or become pregnant during treatment with REVLIMID. See "What is the most important information I should know about REVLIMID?" Do not take REVLIMID if you are allergic to lenalidomide or any of the ingredients in REVLIMID. See the Medication Guide for a complete list of ingredients in REVLIMID. What should I tell my healthcare provider before taking REVLIMID? Before you take REVLIMID, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have kidney problems or receive kidney dialysis treatment have thyroid problems are lactose intolerant. REVLIMID contains lactose. are breastfeeding. REVLIMID must not be used by females who are breastfeeding. It is not known if REVLIMID passes into your breast milk and can harm your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVLIMID and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist. How should I take REVLIMID? Take REVLIMID exactly as prescribed and follow all the instructions of the REVLIMID REMS program Swallow REVLIMID capsules whole with water 1 time a day. Do not open, break, or chew your capsules. REVLIMID may be taken with or without food. Take REVLIMID at about the same time each day. Do not open the REVLIMID capsules or handle them any more than needed. If you touch a broken REVLIMID capsule or the medicine in the capsule, wash the area of your body right away with soap and water. If you miss a dose of REVLIMID and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time. If you take too much REVLIMID, call your healthcare provider right away. Do not share REVLIMID with other people. It may cause birth defects and other serious problems. What should I avoid while taking REVLIMID? See “What is the most important information I should know about REVLIMID?” Females: Do not get pregnant and do not breastfeed while taking REVLIMID. Males: Do not donate sperm Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects. What are the possible side effects of REVLIMID? REVLIMID can cause serious side effects, including: See "What is the most important information I should know about REVLIMID?" Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial. Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) and certain other types of cancers of the skin and other organs. Talk with your healthcare provider about your risk of developing new cancers if you take REVLIMID. Your healthcare provider will check you for new cancers during your treatment with REVLIMID. Severe liver problems, including liver failure and death. Your healthcare provider should do blood tests to check your liver function during your treatment with REVLIMID. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems: yellowing of your skin or the white part of your eyes (jaundice) dark or brown (tea-colored) urine pain on the upper right side of your stomach area (abdomen) bleeding or bruising more easily than normal feeling very tired Serious allergic reactions and serious skin reactions can happen with REVLIMID and may cause death. Call your healthcare provider right away if you develop any of these signs or symptoms of a serious allergic reaction or serious skin reaction during treatment with REVLIMID: swelling of your face, eyes, lips, tongue, throat trouble swallowing trouble breathing skin rash, hives, or peeling of your skin blisters Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure and sometimes death. Your healthcare provider may do blood tests to check you for TLS. Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender swollen lymph nodes, low grade fever, pain, or rash. Thyroid problems. Your healthcare provider may check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID. The most common side effects of REVLIMID include: diarrhea rash nausea constipation tiredness fever itching swelling of the limbs and skin cough These are not all the possible side effects of REVLIMID. Your healthcare provider may tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID if you develop certain serious side effects during treatment with REVLIMID. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide
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