Novel drugs, which are often among the more innovative products in the marketplace, and/or help advance clinical care by providing therapies never before marketed in The United States. Jay Harold’s post, “New Drug for Multiple Sclerosis: OCREVUS is First-in-Class” discusses a significant advance in the treatment of Multiple Sclerosis (MS).
Multiple sclerosis1 (MS) is a nervous system disease that affects your brain and spinal cord. It damages the myelin sheath, the material that surrounds and protects your nerve cells. This damage slows down or blocks messages between your brain and your body, leading to the symptoms of MS. They can include:
- Visual disturbances
- Muscle weakness
- Trouble with coordination and balance
- Sensations such as numbness, prickling, or “pins and needles”
- Thinking and memory problems
MS strikes the Black Community Hard2
There’s some evidence that MS can manifest differently and be especially active in African-Americans:
- more likely to experience more relapses
- more likely to experience greater disability
- have a greater risk of progressing to require ambulatory assistance earlier
- more likely to develop involvement of the optic nerves and spinal cord (optic-spinal MS) and inflammation of the spinal cord (transverse myelitis). A 2004 study published in Neurology reported optic-spinal MS occurs in 17 percent of African-Americans compared with 8 percent of Caucasians. And transverse myelitis affects 28 percent of African-Americans with MS compared with 18 percent of Caucasians.
No one knows what causes MS. It may be an autoimmune disease, which happens when your immune system attacks healthy cells in your body by mistake. Multiple sclerosis affects women more than men. It often begins between the ages of 20 and 40. Usually, the disease is mild, but some people lose the ability to write, speak, or walk.
Treatment of Multiple Sclerosis
Currently, there is no cure for MS. Many individuals do well with no therapy at all, especially since many medications have serious side effects and some carry significant risks. However, three forms of beta interferon3 (Avonex, Betaseron, and Rebif) have now been approved by the Food and Drug Administration for treatment of relapsing-remitting MS. The FDA has also approved a novel drug, ocrelizumab4 (brand name Ocrevus) to treat adults with relapsing forms of MS and primary progressive MS.
Medication Guide for Ocrevus5
Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.
FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:
- certain information is necessary to prevent serious adverse effects
- patient decision-making should be informed by information about a known serious side effect with a product, or
- patient adherence to directions for the use of a product are essential to its effectiveness.
Side Effects of Ocrevus
Infusion reactions: OCREVUS can cause infusion reactions that can be serious and require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:
- itchy skin or trouble breathing or nausea or shortness of breath
- rash or throat irritation or pain or a headache or fatigue
- hives or feeling faint o swelling of the throat or fast heartbeat
- tiredness or fever or dizziness
- coughing or wheezing
- redness on your face (flushing)
These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion.
- OCREVUS increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin
infections, and herpes infections. Tell your healthcare provider if you have an infection or have any of the following
signs of infection including fever, chills, a cough that does not go away, or signs of herpes (such as cold sores,
shingles, or genital sores). These signs can happen during treatment or after you have received your last dose of
OCREVUS. If you have an active infection, your healthcare provider should delay your treatment with OCREVUS until
your infection is gone.
- Progressive Multifocal Leukoencephalopathy (PML): Although no cases have been seen with OCREVUS
treatment, PML may happen with OCREVUS. PML is a rare brain infection that usually leads to death or severe
disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms.
These may include problems with thinking, balance, eyesight, weakness on 1 side of your body, strength, or using
your arms or legs.
- Hepatitis B virus (HBV) reactivation: Before starting treatment with OCREVUS, your healthcare provider will do
blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus
may become active again during or after treatment with OCREVUS. Hepatitis B virus becoming active again (called
reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor
you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving OCREVUS.
- Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system
could increase your risk of getting infections.
What is OCREVUS?
OCREVUS is a prescription medicine used to treat adults with relapsing or primary progressive forms of multiple sclerosis.
It is not known if OCREVUS is safe or effective in children.
Who should not receive OCREVUS?
- Do not receive OCREVUS if you have an active hepatitis B virus (HBV) infection.
- Do not receive OCREVUS if you have had a life-threatening allergic reaction to OCREVUS. Tell your healthcare provider
if you have had an allergic reaction to OCREVUS or any of its ingredients in the past.
- have had a recent vaccination or are scheduled to receive any vaccinations. You should receive any required
vaccines at least 6 weeks before you start treatment with OCREVUS. You should not receive certain vaccines
(called ‘live’ or ‘live attenuated’ vaccines) while you are being treated with OCREVUS and until your healthcare provider
tells you that your immune system is no longer weakened.
- are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm your
unborn baby. You should use birth control (contraception) during treatment with OCREVUS and for 6 months after your
last infusion of OCREVUS.
- are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into your breast milk. Talk to your healthcare
provider about the best way to feed your baby if you take OCREVUS.
How will I receive OCREVUS?
- OCREVUS is given through a needle placed in your vein (intravenous infusion) in your arm.
- Before treatment with OCREVUS, your healthcare provider will give you a corticosteroid medicine and an antihistamine to
help reduce infusion reactions (make them less frequent and less severe). You may also receive other medicines to help
reduce infusion reactions
- Your first full dose of OCREVUS will be given as 2 separate infusions, 2 weeks apart. Each infusion will last about 2 hours
and 30 minutes.
- Your next doses of OCREVUS will be given as one infusion every 6 months. These infusions will last about 3 hours and
For more information, go to www.OCREVUS.com or call 1-844-627-3887.
The Center For Drug Evaluation and Research6 (CDER) identified 15 of the 46 novel drugs approved in 2017 (33%) as first-in-class, which is one indicator of the drug’s potential for strong positive impact on the health of the American people. Ocrevus is one of the 15 novel drugs.
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- https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM591976.pdf (page 9)