Pronunciation:

ra-mue-SIR-ue-mab

Brand Names:

• Cyramza

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Ramucirumab injection is used alone or together with paclitaxel to treat advanced or metastatic (cancer that has already spread) stomach or gastroesophageal junction cancer (GEJ) after a patient has received other cancer medicines (eg, medicines that containing fluoropyrimidine or platinum) but did not work well.

Ramucirumab injection is also together with erlotinib used as first-line treatment for metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) in patients who have certain types of abnormal epidermal growth factor receptor (EGFR) gene (exon 19 deletions or exon 21 mutations). Your doctor will perform a test before you take this medicine.

Ramucirumab injection is also used in combination with docetaxel to treat metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) in patients who have received other cancer medicines (eg, medicines containing platinum). It is given to patients whose tumors have an abnormal EGFR or ALK gene and have tried treatment for these tumors but did not work well.

Ramucirumab injection is also used in combination with folinic acid, 5-fluorouracil, and irinotecan (FOLFIRI) to treat metastatic (cancer that has already spread) colorectal cancer (mCRC) in patients who have received other cancer medicines (eg, bevacizumab, oxaliplatin, or medicines containing fluoropyrimidine) but did not work well.

Ramucirumab injection is also used to treat a type of liver cancer called hepatocellular carcinoma (HCC) in patients who have received other medicines (eg, sorafenib).

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

Before Using This Medicine:

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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ramucirumab 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.

Other 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.

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clotting problems or
• Heart attack, recent or
• Hypertension (high blood pressure) or
• Kidney disease or
• Liver disease (eg, cirrhosis) or
• Stroke, recent or
• Thyroid problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, 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 this medicine in a medical facility. It is given through a needle placed into one of your veins.

This medicine must be given slowly, so the needle will have remain in place for at least 60 minutes.

You may also receive other medicines (eg, allergy medicine, fever medicine, steroids) to help prevent unwanted effects to the injection.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are female and able to get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may 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 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 during treatment with ramucirumab. If you notice any changes to your normal blood pressure, call your doctor right away.

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

This medicine may increase your risk of gastrointestinal perforation (a hole in the stomach with bleeding). Tell your doctor right away if you have severe 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 this medicine. You may need to stop receiving this medicine 28 days before and for at least 14 days after having surgery.

This medicine may increase your risk of blood clotting, including heart attack or stroke. Call your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty breathing, slurred speech, vision changes, or sudden loss of coordination, severe headache, or severe weakness or numbness in arm or leg.

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 increase your chance of having a brain condition called posterior reversible encephalopathy syndrome (PRES). 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.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Talk with your doctor before receiving this medicine if you plan to have children. Some women who use this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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

cloudy urine

confusion

cough

coughing up blood

decreased urine output

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, slow, pounding, or irregular heartbeat or pulse

feeling of warmth

feeling unusually cold

fever

headache

increased thirst

lower back or side pain

muscle pain or cramps

nausea

nervousness

nosebleeds

painful or difficult urination

pounding in the ears

redness of the face, neck, arms, and occasionally, upper chest

seizures

shakiness in the legs, arms, hands, or feet

shivering

sweating

swelling of the face, hands, ankles, feet, or lower legs

trembling or shaking of the hands or feet

trouble breathing

unusual tiredness or weakness

vomiting

Less common

Bleeding gums

difficulty swallowing

dizziness

inability to speak

increased menstrual flow or vaginal bleeding

loss of consciousness

low blood pressure or pulse

pain in the chest, groin, or legs, especially calves of the legs

pain or discomfort in the arms, jaw, back, or neck

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

slurred speech

sore throat

stomach pain, cramping, or burning

sudden loss of coordination

sudden onset of slurred speech

sudden vision changes

sweating

temporary blindness

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

vomiting of material that looks like coffee grounds, severe and continuing

Incidence not known

Full feeling and pain in the upper abdomen

nausea

sudden weakness in the arms or legs

sudden, severe chest pain

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

Cracked lips

diarrhea

hair loss or thinning

swelling or inflammation of the mouth

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.