��)����}��~��,���_��7�Bo���A�"�GR�XIo&��� ~�iF�����gN��/q����k`�̤�YN2�"N��|�9��}�Q3/I�Q�1�i��d���K"�l�~���eNn�n�/����jruw-��~{o�_���w7�}r0U>l����揥��ċ�o�@�i�$�K��,}����XDSM_�I�4�'�텸M��cyAosx�wU�����,��[%�# Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 03/11/2020: SUPPL-4: Labeling-Package Insert Rasuvo is a single-dose manually-triggered auto-injector for once-weekly subcutaneous use only [see Warnings and Precautions (5.5)]. However, methotrexate injectable formulations containing the preservative benzyl alcohol are not recommended for use in neonates. These are not all the possible side effects of Rasuvo. Do you have all the support you need to help you manage your RA and your therapy with Rasuvo?Rasuvo is a single-dose auto-injector containing a prescription medicine, methotrexate. Rasuvo [package insert]. Chicago, IL: Medac Pharma, Inc; March 2018. METHOTREXATE INJECTIONS Otrexup, Rasuvo, RediTrex* (methotrexate) *These medications are included in this policy but are not available in the market as of yet. Methotrexate is used to: Treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non-steroidal anti-inflammatory (NSAIDS) have been used and did not work well. For more information, ask your doctor or pharmacist.For additional information about Rasuvo, please refer to the You are encouraged to report negative side effects of prescription drugs to the FDA. Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of Rasuvo administration [see Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs) [see Methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but generally only after prolonged use. Use is contraindicated during pregnancy. An initial test dose may be given prior to the regular dosing schedule to detect any extreme sensitivity to adverse effects.Maximal myelosuppression usually occurs in seven to ten days.All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Recovery has been reported with discontinuation of therapy [see Potentially fatal opportunistic infections, especially Pneumocystis jiroveci pneumonia, may occur with methotrexate therapy [see Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis [see Rasuvo is a single-dose manually-triggered auto-injector for once-weekly subcutaneous use only [see Warnings and Precautions (5.5)]. endobj Although there is experience with doses up to 30 mg/mTherapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.The optimal duration of therapy is unknown. %���� Rasuvo is only available in doses between 7.5 to 30 mg in 2.5 mg increments. Administer Rasuvo in the abdomen or the thigh.

There have been reports of fatal ‘gasping syndrome’ in neonates (children less than one month of age) following the administrations of intravenous solutions containing the preservative benzyl alcohol.

Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population [see Methotrexate-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion, which may occur acutely at any time during therapy and has been reported at low doses. 12.5 mg per 0.25 mL. Visit Rasuvo is a registered trademark of Medexus Pharma, Inc.© 2019 Medexus Pharma, Inc. All rights reserved. %PDF-1.5 Section 4: Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. Remove one blister-packaged prefilled syringe from the refrigerated carton. FOR SUBCUTANEOUS USE ONLY See full prescribing information for dosage and administration. Warnings and Precautions (5.5)].
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<>>> 3. Advise females and males of reproductive potential to use effective contraception during and after treatment with Rasuvo [see Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Chicago, IL: Medac Pharma Inc.; July 2014. x��[�o�6�^��?�C�H)��0 mӮźti� �]�x��wGF\~?�t��ջ����g���+q��S$����y�,H���������b-�������?�|�Nr-^�������|U5�"�7���i��2�ğ�w���˻�6���>��)����}��~��,���_��7�Bo���A�"�GR�XIo&��� ~�iF�����gN��/q����k`�̤�YN2�"N��|�9��}�Q3/I�Q�1�i��d���K"�l�~���eNn�n�/����jruw-��~{o�_���w7�}r0U>l����揥��ċ�o�@�i�$�K��,}����XDSM_�I�4�'�텸M��cyAosx�wU�����,��[%�# Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 03/11/2020: SUPPL-4: Labeling-Package Insert Rasuvo is a single-dose manually-triggered auto-injector for once-weekly subcutaneous use only [see Warnings and Precautions (5.5)]. However, methotrexate injectable formulations containing the preservative benzyl alcohol are not recommended for use in neonates. These are not all the possible side effects of Rasuvo. Do you have all the support you need to help you manage your RA and your therapy with Rasuvo?Rasuvo is a single-dose auto-injector containing a prescription medicine, methotrexate. Rasuvo [package insert]. Chicago, IL: Medac Pharma, Inc; March 2018. METHOTREXATE INJECTIONS Otrexup, Rasuvo, RediTrex* (methotrexate) *These medications are included in this policy but are not available in the market as of yet. Methotrexate is used to: Treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non-steroidal anti-inflammatory (NSAIDS) have been used and did not work well. For more information, ask your doctor or pharmacist.For additional information about Rasuvo, please refer to the You are encouraged to report negative side effects of prescription drugs to the FDA. Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of Rasuvo administration [see Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs) [see Methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but generally only after prolonged use. Use is contraindicated during pregnancy. An initial test dose may be given prior to the regular dosing schedule to detect any extreme sensitivity to adverse effects.Maximal myelosuppression usually occurs in seven to ten days.All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Recovery has been reported with discontinuation of therapy [see Potentially fatal opportunistic infections, especially Pneumocystis jiroveci pneumonia, may occur with methotrexate therapy [see Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis [see Rasuvo is a single-dose manually-triggered auto-injector for once-weekly subcutaneous use only [see Warnings and Precautions (5.5)]. endobj Although there is experience with doses up to 30 mg/mTherapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.The optimal duration of therapy is unknown. %���� Rasuvo is only available in doses between 7.5 to 30 mg in 2.5 mg increments. Administer Rasuvo in the abdomen or the thigh.

There have been reports of fatal ‘gasping syndrome’ in neonates (children less than one month of age) following the administrations of intravenous solutions containing the preservative benzyl alcohol.

Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population [see Methotrexate-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion, which may occur acutely at any time during therapy and has been reported at low doses. 12.5 mg per 0.25 mL. Visit Rasuvo is a registered trademark of Medexus Pharma, Inc.© 2019 Medexus Pharma, Inc. All rights reserved. %PDF-1.5 Section 4: Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. Remove one blister-packaged prefilled syringe from the refrigerated carton. FOR SUBCUTANEOUS USE ONLY See full prescribing information for dosage and administration. Warnings and Precautions (5.5)].

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