Ramucirumab increased the risk of hemorrhage and gastrointestinal hemorrhage, including severe and sometimes fatal hemorrhagic events. Permanently discontinue ramucirumab in patients who experience severe bleeding. Ramucirumab can also increase the risk of potentially fatal gastrointestinal perforation. Permanent discontinue treatment if this event occurs. Impaired wound healing may occur with antibodies inhibiting the vascular endothelial growth factor pathway. Withhold treatment prior to surgery and discontinue ramucirumab if impaired wound healing or wound healing complications occur .
Ramucirumab injection is used alone or together with paclitaxel to treat advanced stomach or gastroesophageal junction cancer (cancer that has already spread) after a patient has received other cancer medicines. It is also used in combination with docetaxel to treat metastatic non-small cell lung cancer (cancer that has already spread) in patients who have received other cancer medicines. This medicine is also used in combination with folinic acid, 5-fluorouracil, and irinotecan (FOLFIRI) to treat metastatic colorectal cancer (cancer that has already spread) in patients who have received other cancer medicines.
This medicine is to be given only by or under the direct supervision of your doctor.
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:
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.
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.
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.
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.
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.
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:
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 hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.
You may also receive medicines (eg, acetaminophen, dexamethasone, diphenhydramine) to help prevent allergic reactions to the injection.
Your doctor will 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.
Using this medicine while you are pregnant can harm an unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 3 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine 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 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. These 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 using this medicine several days before having surgery.
This medicine 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.
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).
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:
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:
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.