Natalizumab-sztn (Intravenous)

Generic name: natalizumab-sztn [ na-ta-LYE-zoo-mab-- sztn ]
Brand name: Tyruko
Drug class: Selective immunosuppressants

Medically reviewed by Drugs.com. Last updated on Jan 9, 2024.

Intravenous route(Solution)

Progressive Multifocal Leukoencephalopathy Natalizumab products increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab-sztn. Healthcare professionals should monitor patients on natalizumab-sztn for any new sign or symptom that may be suggestive of PML. Natalizumab-sztn dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended. Because of the risk of PML, natalizumab-sztn is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TYRUKO REMS Program .

Uses for natalizumab-sztn

Natalizumab-sztn injection is used to treat the relapsing forms (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease) of multiple sclerosis (MS). This medicine will not cure MS, but it may slow some of the disabling effects and decrease the number of relapses of the disease.

Natalizumab-sztn injection is also used to treat moderate to severe Crohn's disease (CD) when other medicines or treatments did not work well. This medicine will not cure CD, but may prevent it from occurring again.

This medicine is available only under a restricted distribution program called the Tyruko® REMS (Risk Evaluation and Mitigation Strategy) Program.

Before using natalizumab-sztn

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of natalizumab-sztn injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of natalizumab-sztn injection in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Anifrolumab-fnia
Infliximab
Vedolizumab

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper use of natalizumab-sztn

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be injected slowly, so the needle will have to remain in place for about an hour every 4 weeks.

It is very important that you understand the requirements of the Tyruko® REMS program, and become familiar with the Tyruko® medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

Your doctor may need to check your brain before you start receiving this medicine. To do this, you may need to have a Magnetic Resonance Imaging (MRI) scan.

Precautions while using natalizumab-sztn

Your doctor will want to check your progress at 3 months and 6 months after the first injection, then every 6 months after that. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase your risk of developing infections, including a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). This is more likely to occur if you have had JCV infection, have been receiving natalizumab-sztn for a long time (longer than 2 years), or if you have been using medicine that weakens your immune system (eg, azathioprine, cyclophosphamide, cyclosporine, mercaptopurine, methotrexate, mitoxantrone, mycophenolate mofetil, or steroid medicine) before receiving this medicine. Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, or weak legs.

This medicine may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person stops receiving this medicine after developing PML during treatment. Tell your doctor right away if you have an inflammatory reaction to an infection that includes mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin.

Natalizumab-sztn may increase the risk of developing encephalitis, meningitis, or acute retinal necrosis caused by herpes and varicella viruses. Check with your doctor if you have a fever, headache, eye pain or redness, sensitivity of the eyes to the sun, or confusion.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Make sure any doctor or dentist who treats you knows that you are using this medicine.

Side Effects of natalizumab-sztn

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
burning or stinging of the skin
chest tightness
chills
cough
diarrhea
difficult, burning, or painful urination
difficulty in breathing or swallowing
discouragement
dizziness or lightheadedness
facial swelling
fast heartbeat
feeling of constant movement of self or surroundings
feeling sad or empty
fever
frequent urge to urinate
headache
irritability
itching of the vagina or genital area
loss of appetite
loss of interest or pleasure
lower back or side pain
nausea
pain during sexual intercourse
pain or tenderness around eyes and cheekbones
painful cold sores or blisters on the lips, nose, eyes, or genitals
rapid weight gain
sensation of spinning
skin itching, rash, or redness
sneezing
sore throat
stomach pain
stuffy or runny nose
swelling of the face, throat, or tongue
thick, white vaginal discharge with no odor or with a mild odor
tingling of the hands or feet
trouble concentrating
trouble sleeping
unusual tiredness or weakness
unusual weight gain or loss
vomiting

Less common

Bloating
loss of bladder control
sleepiness or unusual drowsiness
stomach or pelvic discomfort, aching, or heaviness

Incidence not known

Back, leg, or stomach pains
black, tarry stools
bleeding gums
blood in the urine or stools
blurred vision
chest pain
confusion
dark urine
feeling of heat, redness, or swelling of the skin
general body swelling
general feeling of illness
mild burning, stinging, or tingling of the skin
nosebleeds
pale skin
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
seizures
stiff neck or back
unusual bleeding or bruising
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common