Oxaliplatin

Oxaliplatin is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Oxaliplatin must be given slowly, and the infusion can take at least 2 hours to complete.

Oxaliplatin is given once every 2 weeks. Your doctor will determine how long to treat you with this medicine.

You may be given medication to prevent nausea or vomiting while you are receiving oxaliplatin.

Receiving oxaliplatin can make you more sensitive to cold, which can cause numbness, tingling, and muscle spasms. This includes exposure to cold temperature and coming into contact with cold objects. To prevent discomfort, follow these steps:

• do not inhale deeply when you are exposed to cold air;
• cover your skin, head, and face when you are outside in cold temperatures;
• wear gloves when handling cold objects or refrigerated foods;
• do not run an air conditioner at very cool temperature in your home or car (even during hot weather);
• do not drink cold drinks or use ice cubes in drinks;
• do not put ice packs on your body.

Chemotherapy often causes nausea or mouth sores. Do not eat ice chips to ease these discomforts because you will be more sensitive to cold. Talk to your doctor about other ways to treat nausea or mouth sores. You may be given other medications to prevent nausea or vomiting while you are receiving oxaliplatin.

Oxaliplatin can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Contact your doctor if you miss an appointment for your oxaliplatin injection.

Black Box Warnings

The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to diagnose and manage complications

Anaphylactic-like reactions have been reported and may occur within minutes of administration. Epinephrine, corticosteroids, and antihistamines have been used to treat these symptoms

Contraindications

Hypersensitivity to oxaliplatin, other platinum compounds

Pregnancy

Cautions

Caution in renal impairment, elderly, neuropathy, neurotoxic agents

For 3-4 days, avoid contact with ice/cold food/objects, avoid breathing cold air

Avoid contact with aluminum needles or equipment

Avoid pregnancy

Pulmonary fibrosis may occur

Concomitant use with fluorouracil may increase gastrointestinal effects

Grade 3 or 4 neutropenia reported in patients with colorectal cancer treated in combination with 5-flurouracil (5-FU) and leucovorin; delay oxaliplatin therapy until neutrophils are at 1.5 x 10^9/L; withhold oxaliplatin for sepsis or septic shock; reduce dose after recovery from Grade 4 neutropenia or febrile neutropenia

Cardiovascular toxicity reported; ECG monitoring recommended if therapy initiated in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities; correct hypokalemia or hypomagnesemia prior to initiating oxaliplatin and monitor these electrolytes periodically during therapy; avoid oxaliplatin in patients with congenital long QT syndrome

Reversible posterior leukoencephalopathy syndrome (RPLS, also known as PRES, Posterior Reversible Encephalopathy Syndrome) reported in clinical trials and postmarketing experience

Rhabdomyolysis, including fatal cases reported; discontinue oxaliplatin if any signs or symptoms of rhabdomyolysis occur

Oxaliplatin is a prescription medication used to treat advanced colon or rectal cancer in adults. Oxaliplatin belongs to a group of drugs called platinum-containing antineoplastic agents, which stops cancer cells from multiplying.

This medication comes in an injectable form to be given intravenously (into a vein) at a hospital or clinic on the first day of each chemotherapy treatment course.

Some of the common side effects of oxaliplatin are decreased blood count, high blood pressure, and diarrhea. 

Oxaliplatin is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Oxaliplatin must be given slowly, and the infusion can take at least 2 hours to complete.

Oxaliplatin is given once every 2 weeks. Your doctor will determine how long to treat you with this medicine.

You may be given medication to prevent nausea or vomiting while you are receiving oxaliplatin.

Receiving oxaliplatin can make you more sensitive to cold, which can cause numbness, tingling, and muscle spasms. This includes exposure to cold temperature and coming into contact with cold objects. To prevent discomfort, follow these steps:

• do not inhale deeply when you are exposed to cold air;

• cover your skin, head, and face when you are outside in cold temperatures;

• wear gloves when handling cold objects or refrigerated foods;

• do not run an air conditioner at very cool temperature in your home or car (even during hot weather);

• do not drink cold drinks or use ice cubes in drinks;

• do not put ice packs on your body.

Chemotherapy often causes nausea or mouth sores. Do not eat ice chips to ease these discomforts because you will be more sensitive to cold. Talk to your doctor about other ways to treat nausea or mouth sores. You may be given other medications to prevent nausea or vomiting while you are receiving oxaliplatin.

Oxaliplatin can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

General

• Administer on day 1 as part of a 2-day combination regimen.1

• Premedication with antiemetics, including selective inhibitors of type 3 serotonergic (5-HT3) receptors (e.g., dolasetron, granisetron, ondansetron) with or without dexamethasone, recommended prior to each 2-day cycle.1

• Hydration prior to administration not necessary.1

• Handle cautiously (e.g., use gloves) to avoid exposure to oxaliplatin during preparation of IV solutions.1 Immediately treat accidental contact; wash skin thoroughly with soap and water or flush mucosa with copious amounts of water.1 Consult specialized references for procedures for proper handling and disposal of antineoplastics.

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.1

Flush infusion line with 5% dextrose injection prior to administration of oxaliplatin or any concomitant drug.1 7

Aluminum may cause degradation of platinum compounds; do not use needles or IV administration sets that contain aluminum parts for reconstitution or dilution.1

Administer leucovorin by IV infusion concurrently with oxaliplatin but in a separate container using a Y-type administration set.1 Administer fluorouracil by direct IV injection (over 2–4 minutes), then by IV infusion.1 Consult respective manufacturer’s prescribing information for additional information on reconstitution and administration of fluorouracil and leucovorin.1

Reconstitute vial containing 50 or 100 mg of oxaliplatin powder with 10 or 20 mL, respectively, of water for injection or 5% dextrose injection to provide a solution containing 5 mg/mL.7

Must be diluted further before IV administration.1

Reconstituted solution or commercially available concentrate (5 mg/mL) must be further diluted prior to IV administration.1

Withdraw appropriate dose of oxaliplatin and dilute in 250–500 mL of 5% dextrose injection.1

Manufacturer of oxaliplatin recommends leucovorin and fluorouracil for IV infusion be diluted with 5% dextrose injection.1

Administer oxaliplatin over 2 hours.1

Administer leucovorin over 2 hours.1

Administer fluorouracil injection over 2–4 minutes followed by an IV infusion over 22 hours.1

Dosage

Adults

Administer oxaliplatin/fluorouracil/leucovorin (FOLFOX4) regimen over 2 consecutive days.1 13

On day 1, administer oxaliplatin 85 mg/m2 concurrently with leucovorin 200 mg/m2 (in separate containers) by IV infusion over 2 hours.1 Then administer fluorouracil 400 mg/m2 by IV injection over 2–4 minutes, followed by fluorouracil 600 mg/m2 by IV infusion over 22 hours.1

On day 2, administer leucovorin 200 mg/m2 by IV infusion over 2 hours.1 Then administer fluorouracil 400 mg/m2 by IV injection over 2–4 minutes, followed by fluorouracil 600 mg/m2 by IV infusion over 22 hours.1

Repeat regimen at intervals of 2 weeks for a total of 12 cycles (6 months).1 9

Alternative regimen (modified FOLFOX6): On day 1, administer oxaliplatin 85 mg/m2 concurrently with leucovorin 400 mg/m2 (in separate containers) by IV infusion over 2 hours.12 13 Then administer fluorouracil 400 mg/m2 by IV injection over 5 minutes, followed by fluorouracil 1200 mg/m2 by IV infusion daily for 2 days (i.e., 2400 mg/m2 by IV infusion over 46–48 hours [total fluorouracil dosage of 2800 mg/m2 per cycle]).12 13 Repeat regimen at intervals of 2 weeks.13

Dosage of 130 mg/m2 IV over 2 hours on day 1 in combination with capecitabine† 1 g/m2 orally twice daily on days 1–14 of each 3-week cycle, for a total of 8 cycles, also has been used.10001 10006

To minimize acute toxicities, administer oxaliplatin over 6 hours; adjustment of infusion duration for fluorouracil or leucovorin not necessary.1

If persistent grade 2 adverse neurosensory effects occur, consider reducing oxaliplatin dosage to 75 mg/m2; dosage modification for fluorouracil or leucovorin not required.1 Consider drug discontinuance if persistent grade 3 neurosensory effects occur.1

In patients who have recovered from grade 3 or 4 GI toxicity (that occurred despite prophylactic treatment), grade 4 neutropenia, or grade 3 or 4 thrombocytopenia, reduce oxaliplatin dosage to 75 mg/m2 and reduce fluorouracil dosage by approximately 20% (i.e., to 300 mg/m2 by IV injection over 2–4 minutes and 500 mg/m2 by IV infusion over 22 hours).1 Do not administer next dose until neutrophil count ≥1500/mm3 and platelet count ≥75,000/mm3.1

Administer oxaliplatin/fluorouracil/leucovorin (FOLFOX4) regimen over 2 consecutive days.1 13

On day 1, administer oxaliplatin 85 mg/m2 concurrently with leucovorin 200 mg/m2 (in separate containers) by IV infusion over 2 hours.1 Then administer fluorouracil 400 mg/m2 by IV injection over 2–4 minutes, followed by fluorouracil 600 mg/m2 by IV infusion over 22 hours.1

On day 2, administer leucovorin 200 mg/m2 by IV infusion over 2 hours.1 Then administer fluorouracil 400 mg/m2 by IV injection over 2–4 minutes, followed by fluorouracil 600 mg/m2 by IV infusion over 22 hours.1

Repeat regimen at intervals of 2 weeks.1 Continue therapy until disease progression or unacceptable toxicity occurs.1 11

Alternative regimen (modified FOLFOX6): On day 1, administer oxaliplatin 85 mg/m2 concurrently with leucovorin 400 mg/m2 (or, alternatively, leucovorin 350 mg) (in separate containers) by IV infusion over 2 hours.12 13 Then administer fluorouracil 400 mg/m2 by IV injection over 5 minutes, followed by fluorouracil 1200 mg/m2 by IV infusion daily for 2 days (i.e., 2400 mg/m2 by IV infusion over 46–48 hours [total fluorouracil dosage of 2800 mg/m2 per cycle]).12 13 Repeat regimen at intervals of 2 weeks.12 13

To minimize acute toxicities, administer oxaliplatin over 6 hours; adjustment of infusion duration for fluorouracil or leucovorin not necessary.1

If persistent grade 2 adverse neurosensory effects occur, consider reducing the oxaliplatin dosage to 65 mg/m2; dosage modification for fluorouracil or leucovorin not required.1 Consider drug discontinuance if persistent grade 3 neurosensory effects occur.1

In patients who have recovered from grade 3 or 4 GI toxicity (that occurred despite prophylactic treatment), grade 4 neutropenia, or grade 3 or 4 thrombocytopenia, reduce oxaliplatin dosage to 65 mg/m2 and reduce fluorouracil dosage by approximately 20% (i.e., to 300 mg/m2 by IV injection over 2–4 minutes and 500 mg/m2 by IV infusion over 22 hours).1 Do not administer next dose until neutrophil count ≥1500/mm3 and platelet count ≥75,000/mm3.1

Special Populations

Renal Impairment

Safety and efficacy not established; use with caution.1

Geriatric Patients

No adjustment of initial dosage was necessary in geriatric patients ≥65 years of age receiving oxaliplatin in combination with fluorouracil and leucovorin as second-line therapy for advanced colorectal cancer.1

• If you have an allergy to this medicine or any part of oxaliplatin.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Long QT on ECG, low magnesium levels, or low potassium levels.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take oxaliplatin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how oxaliplatin affects you.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• Numbness, tingling, or burning of the feet or hands or around the mouth or in the throat may happen with this medicine. Cold temperatures can make it worse. Avoid cold food or drinks. Always drink through a straw. Dress warmly and cover the skin if you go out in the cold. Wear socks or gloves if you have to touch cold objects like cold flooring or items in the refrigerator or freezer.
• Some people may have nerve problems that cause problems with daily living. Sometimes, this may lead to long-lasting or life-threatening problems. Call your doctor right away if you have burning, numbness, or tingling that bothers you or causes problems with daily living. Call your doctor right away if you have problems walking, talking, swallowing, or saying words. Call your doctor right away if you have eye pain, jaw tightness, a strange feeling in the tongue, or chest pressure.
• A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with oxaliplatin. Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
• Very bad and sometimes deadly lung problems have happened with this medicine. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.
• This medicine may cause a very bad and sometimes deadly heartbeat that is not normal (long QT on ECG, torsades de pointes). Sometimes, this has happened in people who are not at risk for these health problems. Talk with the doctor.
• A certain muscle problem (rhabdomyolysis) has happened with oxaliplatin. Rarely, this has led to organ problems and death. Call your doctor right away if you have muscle pain or weakness.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking oxaliplatin, call your doctor right away.
• Use birth control that you can trust to prevent pregnancy while taking this medicine.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Feeling very tired or weak.
• Very bad dizziness or passing out.
• A heartbeat that does not feel normal.
• A fast heartbeat.
• Very loose stools (diarrhea).
• Hearing loss.
• Chest pain.
• Sweating a lot.
• Flushing.
• Swelling.

Oxaliplatin Injection is supplied in single-use vials containing 50 mg, 100 mg or 200 mg of Oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.

NDC 7277-001-05:
Oxaliplatin Injection, USP
50 mg/10 mL
(5 mg/mL)
Must be diluted
CYTOTOXIC AGENT
See package insert for further required dilution.
DO NOT MIX OR ADD TO SODIUM CHLORIDE/CHLORIDE-CONTAINING SOLUTIONS
Sterile
FOR INTRAVENOUS USE ONLY
Rx only
Single-Use Vial

No dosage adjustment necessary. Refer to adult dosing.

Manufacturer's US labeling:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: Reduce dose from 85 mg/m2 to 65 mg/m2.

Alternate recommendations: CrCl ≥20 mL/minute: In a study with a limited number of patients with mild to moderate impairment, defined by the authors as CrCl 20 to 59 mL/minute (determined using 24-hour urine collection), oxaliplatin was well tolerated, suggesting a dose reduction may not be necessary in patients with CrCl ≥20 mL/minute receiving every-3-week dosing (dose range: 80 to 130 mg/m2 every 3 weeks) (Takimoto 2003).

Concerns related to adverse effects:

• Bone marrow suppression: Grade 3 and 4 neutropenia occurs commonly with oxaliplatin in combination with fluorouracil and leucovorin; sepsis, neutropenic sepsis, and septic shock have been reported with oxaliplatin (some fatal). Delay oxaliplatin treatment until neutrophils are ≥1500/mm3; withhold treatment for sepsis or septic shock. Reduce the dose after recovery from grade 4 neutropenia or neutropenic fever.

• Cardiotoxicity: QT prolongation and ventricular arrhythmias, including fatal torsades de pointes have been reported in postmarketing surveillance. ECG monitoring is recommend in patients with heart failure, bradyarrhythmias, concomitant medications known to cause QT prolongation (including class Ia and III antiarrhythmics), and electrolyte abnormalities. Avoid use in patients with congenital long QT syndrome. Monitor potassium and magnesium prior to and periodically during treatment; correct hypokalemia and hypomagnesemia prior to treatment initiation.

• Extravasation: Oxaliplatin is an irritant with vesicant-like properties; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.

• GI toxicity: Oxaliplatin is associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Basch 2011; Dupuis 2011; Roila 2016). Fluorouracil and leucovorin are associated with GI adverse events; the incidence of GI toxicity is increased when oxaliplatin is administered with fluorouracil and leucovorin. Mucositis, stomatitis, GI bleeding, and GI obstruction have been reported.

• Hypersensitivity/anaphylactoid reactions: [US Boxed Warning]: Anaphylactic reactions have been reported with oxaliplatin (may occur within minutes of administration); symptoms may be managed with epinephrine, corticosteroids, antihistamines, and discontinuation; oxygen and bronchodilators have also been used (Kim 2009). Grade 3 or 4 hypersensitivity has been observed. Allergic reactions are similar to reactions reported with other platinum analogs and may occur with any cycle. Reactions typically occur after multiple cycles; in retrospective reviews, reaction occurred at a median of 7 to 9 cycles, with an onset of 5 to 70 minutes (Kim 2009; Polyzos 2009). Symptoms may include bronchospasm (rare), erythema, hypotension (rare), pruritus, rash, and/or urticaria; previously-untreated patients have also experienced flushing, diaphoresis, diarrhea, shortness of breath, chest pain, hypotension, syncope, and disorientation. According to the manufacturer, rechallenge is contraindicated (deaths due to anaphylaxis have been associated with platinum derivatives). In patients rechallenged after mild hypersensitivity, reaction recurred at a higher level of severity; for patients with severe hypersensitivity, rechallenge (with 2 to 3 days of antihistamine and corticosteroid premedication, and prolongation of infusion time) allowed for 2 to 4 additional oxaliplatin cycles; however, rechallenge was not feasible in nearly two-thirds of patients due to the severity of the initial reaction (Polyzos 2009).

• Hepatotoxicity: Hepatotoxicity (including rare cases of hepatitis and hepatic failure) has been reported. Liver biopsy has revealed peliosis, idiopathic noncirrhotic portal hypertension (including nodular regenerative hyperplasia), sinusoidal alterations, perisinusoidal fibrosis, and veno-occlusive lesions. The presence of hepatic vascular disorders (including veno-occlusive disease) should be considered, especially in individuals developing portal hypertension or who present with increased liver function tests.

• Neuropathy: Two different types of peripheral sensory neuropathy may occur: The first type of neuropathy is an acute presentation (within hours to 1 to 2 days), reversible (resolves within 14 days), with primarily peripheral symptoms that are often exacerbated by cold (may include pharyngolaryngeal dysesthesia); avoid mucositis prophylaxis with ice chips, exposure to cold temperatures, or consumption of cold food/beverages during or within hours after oxaliplatin infusion (may exacerbate symptoms); this acute neuropathy commonly recurs with subsequent doses. Cold-triggered neuropathy may last up to 7 days after oxaliplatin administration (Grothey 2011). The second type of neuropathy is a more persistent (>14 days) presentation that often interferes with daily activities (eg, writing, buttoning, swallowing); these symptoms may improve in some patients upon discontinuing treatment. In a retrospective evaluation of patients treated with oxaliplatin for colorectal cancer, the incidence of peripheral sensory neuropathy was similar between diabetic and nondiabetic patients (Ramanathan 2010). Several retrospective studies (as well as a small, underpowered randomized trial) have suggested calcium and magnesium infusions before and after oxaliplatin administration may reduce incidence of cumulative sensory neuropathy; however, a recent abstract of an ongoing randomized, placebo-controlled, double-blind study in patients with colorectal cancer suggests there is no benefit of calcium and magnesium in preventing sensory neuropathy or in decreasing oxaliplatin discontinuation rates (Loprinzi 2013).

• Pulmonary toxicity: May cause pulmonary fibrosis (may be fatal); withhold treatment for unexplained pulmonary symptoms (eg, crackles, dyspnea, nonproductive cough, pulmonary infiltrates) until interstitial lung disease or pulmonary fibrosis are excluded.

• Reversible posterior leukoencephalopathy syndrome: Cases of reversible posterior leukoencephalopathy syndrome (RPLS) have been reported. Signs/symptoms include headache, mental status changes, seizure, blurred vision, blindness and/or other vision changes; may be associated with hypertension. Diagnosis is confirmed with brain imaging.

• Rhabdomyolysis: Rhabdomyolysis (including fatal cases) has been reported with oxaliplatin. Discontinue if signs/symptoms of rhabdomyolysis occur.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; increased toxicity may occur. Reduce initial dose in severe impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Elderly patients are more sensitive to adverse events, particularly diarrhea, dehydration, hypokalemia, leukopenia, fatigue, and syncope.

Other warnings/precautions:

• Administration: Oxaliplatin is for IV administration. Administration via the intraperitoneal route (not an approved administration route) is associated with peritoneal hemorrhage and hemorrhagic complications (Charrier 2016).

Adverse events were observed in animal reproduction studies at one-tenth the equivalent human dose. Women of childbearing potential should be advised to avoid pregnancy and use effective contraception during treatment. Males and females of reproductive potential desiring children should consider fertility preservation prior to therapy (Levi 2015; O'Neil 2011).

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, constipation, abdominal pain, loss of strength and energy, lack of appetite, back pain, nausea, vomiting, mouth sores, insomnia, change in taste, or hair loss. Have patient report immediately to prescriber signs of infection, signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any bleeding that is very bad or that will not stop), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or nausea or vomiting), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), dysphagia, abnormal gait, difficulty with fine motor skills, severe dizziness, passing out, severe diarrhea, tachycardia, burning or numbness feeling, vision changes, hearing loss, angina, sweating a lot, flushing, edema, jaw tightness, arrhythmia, eye pain, tongue pain, severe muscle pain, severe muscle weakness, signs of posterior reversible encephalopathy syndrome (illogical thinking, not alert, vision changes, seizures, or severe headache), signs of a severe pulmonary disorder (lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse), or severe injection site pain or irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.