higher frequency than in placebo-treated patients are shown in the table below: Table 7: Adverse Reactions What are the uses for epoetin alfa?
clinical trials of a drug cannot be directly compared to rates in the clinical Visit the FDA MedWatch website or call 1-800-FDA-1088. H�\�͎�0��y/��">f �!U� ������A�������ύ�^u�Q�lG>�/�/�qXL�c��c\L?��o���9��0p��I�K;e:||�-�r��i����o��f�>�C���~4]�����y���~���x���x��b���~]x��N��K4e~�`c�^!\�x���vq��[3��z�����D�� pN� �F�g�g�[v;*�J���V�xZ�V��I�@�:"AT�'��P�P�P�P�P�P�P�P�P�P�P�P�P�P�P�P�G�h��h*.J8�\5wH8�ʒx�, gӅ�, /;(K"��%�ޱ#���Z�QӍ�uAvЍ���A7;t#�vx�����=�F�qu6����f�Z��l�l�sۚ�E}.GA���Va9��K��˯�:9�^������r�����r�R��g/��Ѻg/�x�6�����198\8�އS��s�]2edqJ c|���u�)�>E�� `� For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. studies. Study C1, a 16-week, double-blind, placebo-controlled study that enrolled 344 PROCRIT is not indicated for use: • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy (1.5). Generic Drugs, Are They as Good as Brand-Names? Do not use PROCRIT if the liquid in the vial looks discolored or cloudy, or if the liquid has lumps, flakes, or particles. home Sign Up for MedicineNet Newsletters! Surgery patients should receive 300 units/kg per day daily for 14 days or 600 units/kg weekly. Common side effects of Procrit are: Procrit is available in vials; 1 mL of solution contains 2000, 3000, 4000 or 10,000 Units of Epoetin alfa. reactions are discussed in greater detail in other sections of the label: Because clinical trials are conducted thirty-three (55%) patients were men. >g�1~Ĝ����X/�/����b��WԖ'B��r�?�������9�Y� �5���|VN7G���~1=�U崀�Ӕi>�"�����Ç�j�O�40�VE5~�>/V�|J��: ���|Z���ӂ�hP�ߡxt�Yd���e�XE���ƝC�o��جa���aA%F���.��{��e�6��a�|k)*G�|��0�E�J4�Ew�8*iF���#�|(S>��j�Gx�X��d}�ן�?~��\��$����5U?.����{r�C�(`�_�%L�TAMt�v=m�OŜ�h���K����+�g�u�{��C�*��bMW�O�,�p[Ί���b�Ͻ]U��r��.�����v�R�L�V&I;oR=��Bq�H ��P��K.� DESCRIPTION. A total of 358 proteins, there is a potential for immunogenicity. PROCRIT may also be used to reduce the chance you will need red blood cell transfusions if you are scheduled for certain surgeries where a lot of blood loss is expected. 60,000 IU subcutaneously (mean weekly dose was 49,000 IU). dialysis and greater than placebo were erythema (0.8% PROCRIT and 0% placebo) of ≥ 1% in patients treated with PROCRIT were: Table 5: Adverse Reactions
including irritation and pain. Epoetin alfa can cause serious side effects, including heart attack or stroke. It should not be frozen. The following adverse reactions
Rare cases of seizures or severe rash have occurred in these patients. PROCRIT may also be used to reduce the chance you will need red blood cell transfusions if you are scheduled for certain surgeries where a lot of blood loss is expected. endstream endobj startxref For patients who do not respond adequately over a 12-week escalation period, increasing the PROCRIT, If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of PROCRIT. 29 and 89 years were enrolled. administered once weekly for an average of 13 weeks at a dose of 20,000 to �(ټT�=�{� ���mI��~-GA���Va9��K?���/�j9�^���k9��_�Q�g/������W��{��H�W��U��~�r�\.܆�*ܦ)�1Y������>~l�qyʤO�}�#� ��i�
What is epoetin alfa? The following serious adverse Multiple-use vials should be used within 21 days of the first use. zidovudine-treated HIV-infected patients were studied in 4 placebo-controlled WARNINGS AND PRECAUTIONS]. Epoetin alfa belongs to a class of drugs called colony-stimulating factors because of their ability to stimulate cells in the bone marrow to multiply and form colonies of identical cells. randomized to placebo received at least 1 placebo dose. The dose is tailored to each patient based on targeted hemoglobin levels. Epoetin alfa is also used to treat anemia in individuals with HIV infection and in patients with cancer who are receiving chemotherapy. In HIV-infected patients receiving zidovudine, the most common side effects with epoetin alfa are fever, headache, rash, and nasal or chest congestion. The smallest effective dose should be used. patients and greater than placebo was thrombosis (2.7% PROCRIT and 1% placebo) [see Which drugs or supplements interact with epoetin alfa? AND PRECAUTIONS]. pain or redness where the medicine was injected. Asian, 3 (1%) patients were other, and racial information was missing for 2 PROCRIT was administered at doses between 100 and 200 Units/kg 3 times weekly Our Procrit Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Seek emergency medical help if you have: Read the entire detailed patient monograph for Procrit (Epoetin Alfa). If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of PROCRIT. The most common side effects of epoetin alfa in patients with kidney failure on dialysis are: Rare cases of stinging at the injection site, skin rash and flu-like symptoms (joint and muscle pain) have occurred within a few hours following administration. When fewer red blood cells are produced, you can develop a condition called anemia.. Epoetin alfa is used … For these reasons, comparison Epoetin alfa should be stored at 2 C - 8 C (36 F - 46 F). Other colony-stimulating factors include filigrastim (Neupogen) and sargramostim (Leukine).
epoetin alfa that cross-react with endogenous erythropoietin and other ESAs can
Cancer is a disease caused by an abnormal growth of cells, also called malignancy. The product contains the identical amino acid sequence of isolated natural erythropoietin. Additionally, the observed incidence of antibody (including neutralizing The most common side effects in patients undergoing surgery with anemia are: Blood clots in veins, referred to as a deep venous thrombosis, also may occur. patients were randomly assigned to receive PROCRIT and 103 (22%) patients were and myocardial infarction (0.8% PROCRIT and 0% placebo) [see WARNINGS Do not increase the dose more frequently than once every 4 weeks. mean age of patients was 57 years (range: 24 to 79 years). Allergic reactions, seizures, and thrombotic events (for example, heart attacks, strokes, and pulmonary embolism ) rarely occur. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. The FDA approved epoetin alfa in June 1989. k��h�}���gf�YΜ=��h�} ���)�!�(pGp���`���`�@F�)�� twenty-one (58%) patients were men. 4 weeks. J�RO��*�gAP�&��Q����@P>@P>@P>@P>@P>@P>@P>@P>@P>@P>@P>@P>@P>@P>@P>@P>U�ͦ�پ�C g�K�䄄�U �,��eI8�.� eIXx��,�4 (K"�cG@Ye� ޣ� �LЍ���� �� ��H��n$,�r���_��%, randomly assigned to receive placebo. Get emergency medical help if you have signs of an allergic reaction (hives, sweating, rapid pulse, wheezing, trouble breathing, severe dizziness or fainting, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling). Under normal conditions, when the body senses a decrease in red blood cells or a deficiency in the supply of oxygen, more erythropoietin is produced, and this increases the number of red blood cells. Iron supplements, vitamin B12 injections, and certain medications may also be necessary. PROCRIT and 153 (52%) patients were randomly assigned to receive placebo. PROCRIT (epoetin alfa) is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology.It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. Epoetin alfa is a man-made form of a protein that helps your body produce red blood cells. in Cancer Patients. Terms of Use. Pharmacology, adverse reactions, warnings and side effects. treatment groups, a total of 90 (25%) and 268 (75%) women between the ages of Donot use a vial of PROCRIT if the color cap on the top of the vial has been removed or is … Polyhydramnios and intrauterine growth restriction was reported in a small number of pregnant women who received epoetin alpha. One hundred and Asian, and 5 (1%) other. were Asian, 12 (5%) patients were other, and racial information was missing for used to identify the adverse reactions to PROCRIT. In these studies, the The recommended starting dose for pediatric patients (ages 1 month or older) is 50 Units/kg 3 times weekly intravenously or subcutaneously. of adverse reactions is voluntary and from a population of uncertain size, it It is a product of the genetic engineering of ovarian cells of the Chinese hamster and is produced through recombinant DNA technology in bacteria. It is not known if epoetin alfa is excreted into breast milk.
Epoetin alfa is administered intravenously or subcutaneously (under the skin) at 50-100 units/kg of body weight, three times weekly. The data below were obtained in
The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously.
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