Description
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.
This product is available in the following dosage forms:
- Solution
Before Using
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 ramucirumab 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 ramucirumab injection in the elderly.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
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