Generic Name: Ramucirumab Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: C

Uses

What is Ramucirumab used for?

Ramucirumab is used alone or with another medication (such as paclitaxel) to treat certain cancers (stomach and gastroesophageal cancer). It may also be used with other medication(s) to treat lung, rectal, or colon cancer. It works by slowing or stopping the growth of cancer cells.

How should I take Ramucirumab?

This medication is given by slow injection (usually over 60 minutes) into a vein by a health care professional. It is given as directed by your doctor, usually every 2 weeks to treat stomach, colon, or rectal cancer and every 3 weeks to treat lung cancer. To decrease the risk of injection side effects, you doctor will also prescribe medications (such as antihistamines, acetaminophen) for you to receive before each injection. Carefully follow your doctor’s instructions.

The dosage is based on your medical condition, weight, and response to treatment.

You should receive this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.

How do I store Ramucirumab?

Store intact vials at 2°C to 8°C (36°F to 46°F); do not freeze. Retain in original carton to protect from light. Do not shake. Solutions diluted in NS for infusion may be stored at 2°C to 8°C (36°F to 46°F) for no longer than 24 hours (do not freeze) or may be stored for 4 hours at room temperature (below 25°C [77°F]); do not shake diluted product.

There may be different brands of Ramucirumab that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Ramucirumab down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Ramucirumab?

Before receiving ramucirumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, kidney disease, liver disease, recent surgery, recent injuries/wounds, bleeding/blood problems (such as bleeding of the stomach/intestines).

Ramucirumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery or any medical procedure, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may cause wounds to heal slowly or poorly. Before having surgery, talk with your doctor about the risks and benefits of this medication. Your doctor may tell you to temporarily stop treatment with this medication before surgery. Ask your doctor for specific instructions about when to stop and when to restart treatment with ramucirumab. Tell your doctor right away if you have wounds that are not healing well.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits, and ask your doctor which reliable forms of birth control to use during and for 3 months after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Ramucirumab during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Ramucirumab. Ramucirumab is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Ramucirumab?

Diarrhea, headache, nausea, vomiting, mouth sores, or weakness may occur. Injection reactions such as shaking, back pain/spasms, chest tightness, chills, flushing, rapid heartbeat, dizziness, or skin tingling/burning may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine, swelling hands/ankles/feet), redness/blisters/swelling/pain on the palms of your hands or soles of your feet.

Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, slurred speech, confusion, sudden vision changes, seizure.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ramucirumab?

Ramucirumab may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Ramucirumab?

Ramucirumab may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Ramucirumab?

Ramucirumab may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Ramucirumab.

What is the dose of Ramucirumab for an adult?

Usual Adult Dose for Gastric Cancer

8 mg/kg IV every 2 weeks

Comments:

-This drug is administered either as a single agent or in combination with weekly paclitaxel. When given in combination, this drug should be administered prior to administration of paclitaxel.

-Continue use until disease progression or unacceptable toxicity.

-Do not administer this drug as an IV push or bolus.

-Prior to each drug infusion, all patients should be premedicated with an IV histamine H1 antagonist (e.g., diphenhydramine).

-Patients who have developed a Grade 1 or 2 infusion reaction should also be premedicated with dexamethasone (or equivalent) and acetaminophen prior to each drug infusion.

Use: Treatment of advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Usual Adult Dose for Non-Small Cell Lung Cancer

10 mg/kg IV over 60 minutes on day 1 of a 21 day cycle prior to docetaxel infusion

Comments:

-This drug should be administered prior to administration of docetaxel.

-Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving this drug.

-Continue use until disease progression or unacceptable toxicity.

-Do not administer this drug as an IV push or bolus.

-Prior to each drug infusion, all patients should be premedicated with an IV histamine H1 antagonist (e.g., diphenhydramine).

-Patients who have developed a Grade 1 or 2 infusion reaction should also be premedicated with dexamethasone (or equivalent) and acetaminophen prior to each drug infusion.

Use: This drug, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy

Usual Adult Dose for Colorectal Cancer

8 mg/kg IV over 60 minutes every 2 weeks

Comments:

–This drug should be administered prior to administration of FOLFIRI.

-Continue use until disease progression or unacceptable toxicity.

-Do not administer this drug as an IV push or bolus.

-Prior to each drug infusion, all patients should be premedicated with an IV histamine H1 antagonist (e.g., diphenhydramine).

-Patients who have developed a Grade 1 or 2 infusion reaction should also be premedicated with dexamethasone (or equivalent) and acetaminophen prior to each drug infusion.

Use: This drug, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.

Renal Dose Adjustments

No dose adjustment recommended

Liver Dose Adjustments

Mild to moderate hepatic impairment (Child-Pugh A and B): No adjustment recommended

Dose Adjustments

Infusion Related Reactions (IRR):

-Reduce the infusion rate by 50% for Grade 1 or 2 IRRs.

-Permanently discontinue for Grade 3 or 4 IRRs.

Hypertension:

-Interrupt use for severe hypertension until controlled.

-Permanently discontinue use for severe hypertension that cannot be controlled.

Proteinuria:

-Interrupt use for urine protein levels greater than or equal to 2 g/24 hours. Resume treatment at a reduced dose of 6 mg/kg every 2 weeks once the urine protein level returns to less than 2 g/24 hours. If a protein level greater than or equal to 2 g/24 hours reoccurs, interrupt use and reduce the dose to 5 mg/kg every 2 weeks once the urine protein level returns to less than 2 g/24 hours.

-Permanently discontinue use for urine protein levels greater than 3 g/24 hours or for nephrotic syndrome.

Wound Healing Complications:

-Interrupt use prior to scheduled surgery until the wound is fully healed.

Arterial Thromboembolic Events, Gastrointestinal Perforation, or Grade 3 or 4 Bleeding:

-Permanently discontinue use.

Other Comments

Reconstitution/preparation techniques:

-Sodium chloride 0.9% is the only diluent that should be used for reconstitution. Dextrose solutions should not be used.

-Refer to the manufacturer product information.

Administration advice:

-Gently invert the container for adequate mixing.

-Do not dilute with other solutions or co-infuse with other electrolytes or drugs.

-Administer drug via infusion pump over 60 minutes through a separate infusion line.

-Flush the line with sterile sodium chloride (0.9%) solution for injection at the end of the infusion.

Storage requirements:

-Store in a refrigerator at 2C to 8C (36F to 46F)

-Do not freeze the vial.

-The reconstituted solution is stable for 24 hours under refrigeration 2C to 8C (36F to 46F) and for 4 hours at room temperature (below 25C or 77F).

General:

-Protect from light

-Do not shake the vial.

-Discard the vial if matter or discolorations are present.

Patient advice:

-This drug can cause severe bleeding. Contact your healthcare provider if you are bleeding or have symptoms of bleeding (including lightheadedness).

-Your blood pressure should be monitored every 2 weeks or more frequently.

-You should notify your healthcare provider if you experience severe diarrhea, vomiting, or severe abdominal pain.

-This drug can delay wound healing. Discuss any surgical procedures with your healthcare provider.

-Avoid getting pregnant during treatment with this drug and for at least 3 months following your last dose.

-Do not nurse a baby while being treated with this drug.

What is the dose of Ramucirumab for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Ramucirumab available?

Ramucirumab is available in the following dosage forms and strengths:

  • Intravenous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Ramucirumab, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 10, 2018 | Last Modified: August 10, 2018

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