Get the free JUXTAPID REMS Program - fda
Show details
This document outlines the REMS program for JUXTAPID, including goals, elements to assure safe use, implementation systems, and prescriber and pharmacy certification requirements to manage the risk
We are not affiliated with any brand or entity on this form
Get, Create, Make and Sign juxtapid rems program
Edit your juxtapid rems program form online
Type text, complete fillable fields, insert images, highlight or blackout data for discretion, add comments, and more.
Add your legally-binding signature
Draw or type your signature, upload a signature image, or capture it with your digital camera.
Share your form instantly
Email, fax, or share your juxtapid rems program form via URL. You can also download, print, or export forms to your preferred cloud storage service.
Editing juxtapid rems program online
In order to make advantage of the professional PDF editor, follow these steps below:
1
Register the account. Begin by clicking Start Free Trial and create a profile if you are a new user.
2
Prepare a file. Use the Add New button to start a new project. Then, using your device, upload your file to the system by importing it from internal mail, the cloud, or adding its URL.
3
Edit juxtapid rems program. Rearrange and rotate pages, add and edit text, and use additional tools. To save changes and return to your Dashboard, click Done. The Documents tab allows you to merge, divide, lock, or unlock files.
4
Save your file. Select it from your list of records. Then, move your cursor to the right toolbar and choose one of the exporting options. You can save it in multiple formats, download it as a PDF, send it by email, or store it in the cloud, among other things.
With pdfFiller, it's always easy to work with documents. Try it out!
Uncompromising security for your PDF editing and eSignature needs
Your private information is safe with pdfFiller. We employ end-to-end encryption, secure cloud storage, and advanced access control to protect your documents and maintain regulatory compliance.
How to fill out juxtapid rems program
How to fill out JUXTAPID REMS Program
01
Obtain the JUXTAPID REMS Program enrollment form from the official website or your healthcare provider.
02
Fill out the patient information section with accurate personal details.
03
Provide your insurance information if applicable.
04
Include your prescribing physician's details and any necessary authorizations.
05
Sign and date the form to confirm consent and understanding of the risks associated with JUXTAPID.
06
Submit the completed form to the designated REMS program contact via mail, fax, or electronic submission as instructed.
Who needs JUXTAPID REMS Program?
01
Patients who are prescribed JUXTAPID (lomitapide) for the management of homozygous familial hypercholesterolemia (HoFH).
02
Healthcare providers prescribing JUXTAPID to ensure the patient is monitored for risk factors associated with the medication.
Fill
form
: Try Risk Free
People Also Ask about
What are the side effects of the drug Juxtapid?
Overview: Juxtapid is used to treat homozygous familial hypercholesterolemia (HoFH), a rare genetic condition that causes very high cholesterol levels. Common side effects include digestive issues, such as diarrhea, nausea, vomiting, and upset stomach. Serious side effects include liver problems.
What is Juxtapid indication?
JUXTAPID is indicated as an adjunct to a low- diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with
What does Juxtapid do?
Lomitapide is indicated as an adjunct to a low- diet and other lipid-lowering drugs with or without low-density lipoprotein (LDL) apheresis to reduce LDL cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH).
What is the generic for Juxtapid?
Juxtapid (lomitapide) is a microsomal triglyceride transfer protein (MTP) inhibitor. MTP is a protein in your body that helps make cholesterol. Juxtapid (lomitapide) works by blocking MTP, which stops your body from making cholesterol, including low-density lipoprotein cholesterol (LDL-C, a type of "bad cholesterol").
When was Juxtapid approved?
Approval Date: 12/21/2012.
What is Juxtapid used for?
Juxtapid is a prescription medicine used along with diet and other lipid lowering treatments, including low-density lipoprotein (LDL) apheresis where available, in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL (“bad”) cholesterol, total cholesterol, a protein that carries bad cholesterol in
For pdfFiller’s FAQs
Below is a list of the most common customer questions. If you can’t find an answer to your question, please don’t hesitate to reach out to us.
What is JUXTAPID REMS Program?
The JUXTAPID REMS Program is a Risk Evaluation and Mitigation Strategy designed to ensure the safe use of JUXTAPID (lomitapide), a medication used for the treatment of familial hypercholesterolemia.
Who is required to file JUXTAPID REMS Program?
Healthcare providers who prescribe JUXTAPID and pharmacies that dispense it are required to participate in the JUXTAPID REMS Program.
How to fill out JUXTAPID REMS Program?
To fill out the JUXTAPID REMS Program, prescribers must complete an enrollment form with patient and prescriber information, ensuring that all required fields are accurately filled to comply with the program regulations.
What is the purpose of JUXTAPID REMS Program?
The purpose of the JUXTAPID REMS Program is to mitigate the risks associated with the use of JUXTAPID, particularly its potential for causing liver toxicity and to ensure that patients are monitored appropriately.
What information must be reported on JUXTAPID REMS Program?
The information that must be reported includes patient demographics, prescribing healthcare provider details, liver function tests, and any adverse events related to the use of JUXTAPID.
Fill out your juxtapid rems program online with pdfFiller!
pdfFiller is an end-to-end solution for managing, creating, and editing documents and forms in the cloud. Save time and hassle by preparing your tax forms online.
Juxtapid Rems Program is not the form you're looking for?Search for another form here.
Relevant keywords
Related Forms
If you believe that this page should be taken down, please follow our DMCA take down process
here
.
This form may include fields for payment information. Data entered in these fields is not covered by PCI DSS compliance.
