ramucirumab (Intravenous route)

ra-mue-SIR-ue-mab

Intravenous route(Solution)

Ramucirumab is known to increase the risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue ramucirumab in patients who experience severe bleeding .

Commonly used brand name(s)

In the U.S.

  • Cyramza

Available Dosage Forms:

  • Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Monoclonal Antibody

Uses For ramucirumab

Ramucirumab injection is used to treat advanced or metastatic stomach or gastroesophageal junction cancer (cancer that has already spread) after receiving other cancer medicines (eg, fluoropyrimidine- or platinum-containing medicines).

Slideshow: Flashback: FDA Drug Approvals 2013

ramucirumab is to be given only by or under the direct supervision of your doctor.

Before Using ramucirumab

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 ramucirumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ramucirumab 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 ramucirumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of ramucirumab injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Other Medical Problems

The presence of other medical problems may affect the use of ramucirumab. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Blood clotting problems or
  • Cirrhosis or
  • Heart attack, recent or
  • Hypertension (high blood pressure) or
  • Stroke, recent—Use with caution. May make these conditions worse.

Proper Use of ramucirumab

Medicines used to treat cancer are very strong and can have many side effects. Before receiving ramucirumab, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you ramucirumab in a hospital or cancer treatment center. ramucirumab is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 60 minutes.

ramucirumab must be given slowly, so the needle will remain in place for an hour. You may also receive medicines (eg, diphenhydramine, dexamethasone, acetaminophen) to help prevent possible allergic reactions to the injection.

Precautions While Using ramucirumab

Your doctor will check your progress closely while you are receiving ramucirumab. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Using ramucirumab while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 3 months after the last dose of ramucirumab. If you think you have become pregnant while using the medicine, tell your doctor right away.

ramucirumab may also increase your risk of bleeding and cause delay in wound healing. 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. Check with your doctor immediately if you or your child notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.

You may also need to monitor your blood pressure at home every 2 weeks or more frequent during treatment with ramucirumab. If you notice any changes to your normal blood pressure, call your doctor right away.

ramucirumab may cause infusion related reactions. This can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have cough, difficulty with swallowing, dizziness, fast heartbeat, trouble breathing, chest tightness, swelling in your face or hands, fever, chills, itching or hives, or lightheadedness or faintness while you are receiving ramucirumab.

ramucirumab may increase your risk of gastrointestinal perforation. Tell your doctor right away if you have any of the following symptoms: severe abdominal or stomach pain or cramps, bloody, black, or tarry stools, or vomiting of material that looks like coffee grounds.

Make sure any doctor or dentist who treats you knows that you are using ramucirumab. You may need to stop using ramucirumab several days before having surgery.

ramucirumab may increase your chance of having a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Tell your doctor right away if you develop sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are using ramucirumab.

Talk with your doctor before using ramucirumab if you plan to have children. Some men and women who use ramucirumab have become infertile (unable to have children).

ramucirumab Side Effects

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
  • Back pain or spasms
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • chills
  • coma
  • confusion
  • convulsions
  • decreased urine output
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • feeling unusually cold
  • headache
  • increased thirst
  • muscle pain or cramps
  • nausea or vomiting
  • nervousness
  • pounding in the ears
  • redness of the face, neck, arms, and occasionally, upper chest
  • shakiness in the legs, arms, hands, or feet
  • shivering
  • sweating
  • swelling of the face, ankles, or hands
  • trembling or shaking of the hands or feet
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain
  • bleeding gums
  • bloody nose
  • cough
  • coughing up blood
  • difficulty with breathing or swallowing
  • dizziness
  • fever
  • inability to speak
  • increased menstrual flow or vaginal bleeding
  • lower back or side pain
  • no blood pressure or pulse
  • nosebleeds
  • pain or discomfort in the arms, jaw, back, or neck
  • painful or difficult urination
  • pain in the chest, groin, or legs, especially calves of the legs
  • pale skin
  • paralysis
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • severe constipation
  • severe headaches of sudden onset
  • severe numbness, especially on one side of the face or body
  • severe or sudden headache
  • slurred speech
  • sore throat
  • stopping of heart
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sudden vision changes
  • sweating
  • temporary blindness
  • ulcers, sores, or white spots in the mouth
  • unconsciousness
  • unusual bleeding or bruising
Rare
  • Heartburn
  • indigestion
  • severe abdominal or stomach pain, cramping, or burning
  • vomiting of material that looks like coffee grounds, severe and continuing

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
  • Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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