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Camptosar Inj

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Camptosar Injection

Camptosar Injection

Camptosar Inj Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Camptosar Injection (irinotecan hydrochloride) is used to treat cancers of the colon and rectum. It is usually given with other cancer medicines in combination chemotherapy. It is an antineoplastic (anticancer) medication. This medication is available in generic form. Common side effects include nausea or vomiting (may be severe), loss of appetite, constipation, cough, drowsiness, mouth sores, weakness, or trouble sleeping. Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Camptosar is administered as an intravenous infusion over 90 minutes in a weekly or once-every-3-week dosage schedule. Dose is individualized. Camptosar may interact with diuretics (water pills), atazanavir, ketoconazole, rifabutin, rifampin, St. John's wort, or seizure medicines. Tell your doctor all medications you use. Camptosar is not recommended for use during pregnancy. It may harm a fetus. Consult your doctor to discuss using at least 2 forms of birth control (e.g., condoms, birth control pills) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Camptosar (irinotecan hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Camptosar Inj in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • wheezing, feeling short of breath;
  • chest pain, dry cough;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • runny nose, watery eyes, increased sweating, stomach cramps, and flushing (warmth, redness, or tingly feeling);
  • black, bloody, or tarry stools;
  • nausea or vomiting that keeps you from drinking enough fluids;
  • burning, pain, or swelling around the IV needle;
  • sudden numbness or weakness, problems with vision, speech, or balance;
  • swelling, rapid weight gain; or
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, feeling light-headed, or hot and dry skin.

Less serious side effects may include:

  • dizziness;
  • temporary hair loss.
  • loss of appetite, constipation;
  • mild skin rash; or
  • redness or peeling of the skin on your hands and feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Camptosar Inj (Irinotecan Hydrochloride) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Camptosar Inj Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, loss of appetite, constipation, cough, drowsiness, mouth sores, weakness, or trouble sleeping may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, or if you are unable to drink/eat because of nausea/vomiting, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

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: pain/redness/swelling at the injection site or arms/legs, numbness/tingling/burning of arms/legs, black/bloody stools, change in the amount of urine, lung problems (such as shortness of breath, cough).

Get medical help right away if any of these unlikely but serious side effects occur: chest pain, weakness on one side of the body, slurred speech, confusion, trouble breathing.

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.

Irinotecan can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Camptosar Inj (Irinotecan Hydrochloride)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Camptosar Inj FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Common adverse reactions ( > 30%) observed in combination therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, mucositis, neutropenia, leukopenia (including lymphocytopenia), anemia, thrombocytopenia, asthenia, pain, fever, infection, abnormal bilirubin, and alopecia.

Common adverse reactions ( > 30%) observed in single agent therapy clinical studies are: nausea, vomiting, abdominal pain, diarrhea, constipation, anorexia, neutropenia, leukopenia (including lymphocytopenia), anemia, asthenia, fever, body weight decreasing, and alopecia.

Serious opportunistic infections have not been observed, and no complications have specifically been attributed to lymphocytopenia.

First-Line Combination Therapy

A total of 955 patients with metastatic colorectal cancer received the recommended regimens of irinotecan in combination with 5-FU/LV, 5-FU/LV alone, or irinotecan alone. In the two phase 3 studies, 370 patients received irinotecan in combination with 5-FU/LV, 362 patients received 5-FU/LV alone, and 223 patients received irinotecan alone [see DOSAGE AND ADMINISTRATION].

In Study 1, 49 (7.3%) patients died within 30 days of last study treatment: 21 (9.3%) received irinotecan in combination with 5-FU/LV, 15 (6.8%) received 5-FU/LV alone, and 13 (5.8%) received irinotecan alone. Deaths potentially related to treatment occurred in 2 (0.9%) patients who received irinotecan in combination with 5-FU/LV (2 neutropenic fever/sepsis), 3 (1.4%) patients who received 5-FU/LV alone (1 neutropenic fever/sepsis, 1 CNS bleeding during thrombocytopenia, 1 unknown) and 2 (0.9%) patients who received irinotecan alone (2 neutropenic fever). Deaths from any cause within 60 days of first study treatment were reported for 15 (6.7%) patients who received irinotecan in combination with 5-FU/LV, 16 (7.3%) patients who received 5-FU/LV alone, and 15 (6.7%) patients who received irinotecan alone. Discontinuations due to adverse events were reported for 17 (7.6%) patients who received irinotecan in combination with 5FU/LV, 14 (6.4%) patients who received 5FU/LV alone, and 26 (11.7%) patients who received irinotecan alone.

In Study 2, 10 (3.5%) patients died within 30 days of last study treatment: 6 (4.1%) received irinotecan in combination with 5-FU/LV and 4 (2.8%) received 5-FU/LV alone. There was one potentially treatment-related death, which occurred in a patient who received irinotecan in combination with 5-FU/LV (0.7%, neutropenic sepsis). Deaths from any cause within 60 days of first study treatment were reported for 3 (2.1%) patients who received irinotecan in combination with 5-FU/LV and 2 (1.4%) patients who received 5-FU/LV alone. Discontinuations due to adverse events were reported for 9 (6.2%) patients who received irinotecan in combination with 5FU/LV and 1 (0.7%) patient who received 5-FU/LV alone.

The most clinically significant adverse events for patients receiving irinotecan-based therapy were diarrhea, nausea, vomiting, neutropenia, and alopecia. The most clinically significant adverse events for patients receiving 5-FU/LV therapy were diarrhea, neutropenia, neutropenic fever, and mucositis. In Study 1, grade 4 neutropenia, neutropenic fever (defined as grade 2 fever and grade 4 neutropenia), and mucositis were observed less often with weekly irinotecan/5-FU/LV than with monthly administration of 5-FU/LV.

Tables 5 and 6 list the clinically relevant adverse events reported in Studies 1 and 2, respectively.

Table 5: Study 1: Percent (%) of Patients Experiencing Clinically Relevant Adverse Events in Combination Therapiesa

Adverse Event Study 1
Irinotecan + Bolus 5-FU/LV weekly x 4 every 6 weeks
N=225
Bolus 5-FU/LV daily x 5 every 4 weeks
N=219
Irinotecan weekly x 4 every 6 weeks
N=223
Grade 1-4 Grade 3&4 Grade 1-4 Grade 3&4 Grade 1-4 Grade 3&4
TOTAL Adverse Events 100 53.3 100 45.7 99.6 45.7
GASTROINTESTINAL
  Diarrhea 84.9 22.7 69.4 13.2 83 31
   late -- 15.1 -- 5.9 -- 18.4
    grade 3 -- 7.6 -- 7.3 -- 12.6
    grade 4 45.8 4.9 31.5 1.4 43 6.7
   early
Nausea 79.1 15.6 67.6 8.2 81.6 16.1
Abdominal pain 63.1 14.6 50.2 11.5 67.7 13
Vomiting 60.4 9.7 46.1 4.1 62.8 12.1
Anorexia 34.2 5.8 42 3.7 43.9 7.2
Constipation 41.3 3.1 31.5 1.8 32.3 0.4
Mucositis 32.4 2.2 76.3 16.9 29.6 2.2
HEMATOLOGIC
  Neutropenia 96.9 53.8 98.6 66.7 96.4 31.4
    grade 3 -- 29.8 -- 23.7 -- 19.3
    grade 4 -- 24 -- 42.5 -- 12.1
  Leukopenia 96.9 37.8 98.6 23.3 96.4 21.5
  Anemia 96.9 8.4 98.6 5.5 96.9 4.5
  Neutropenic fever -- 7.1 -- 14.6 -- 5.8
  Thrombocytopenia 96 2.6 98.6 2.7 96 1.7
  Neutropenic infection -- 1.8 -- 0 -- 2.2
BODY AS A WHOLE
  Asthenia 70.2 19.5 64.4 11.9 69.1 13.9
  Pain 30.7 3.1 26.9 3.6 22.9 2.2
  Fever 42.2 1.7 32.4 3.6 43.5 0.4
  Infection 22.2 0 16 1.4 13.9 0.4
METABOLIC & NUTRITIONAL
  Bilirubin 87.6 7.1 92.2 8.2 83.9 7.2
DERMATOLOGIC
  Exfoliative dermatitis  0.9 0 3.2 0.5 0 0
  Rash 19.1 0 26.5 0.9 14.3 0.4
  Alopeciab 43.1 -- 26.5 -- 46.1 --
RESPIRATORY
  Dyspnea 27.6 6.3 16.0 0.5 22.0 2.2
  Cough 26.7 1.3 18.3 0 20.2 0.4
  Pneumonia 6.2 2.7 1.4 1.0 3.6 1.3
NEUROLOGIC
  Dizziness 23.1 1.3 16.4 0 21.1 1.8
  Somnolence 12.4 1.8 4.6 1.8 9.4 1.3
  Confusion 7.1 1.8 4.1 0 2.7 0
CARDIOVASCULAR
  Vasodilatation 9.3 0.9 5.0 0 9.0 0
  Hypotension 5.8 1.3 2.3 0.5 5.8 1.7
  Thromboembolic eventsc 9.3 -- 11.4 -- 5.4 --
aSeverity of adverse events based on NCI CTC (version 1.0)
bComplete hair loss = Grade 2
cIncludes angina pectoris, arterial thrombosis, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, embolus lower extremity, heart arrest, myocardial infarct, myocardial ischemia, peripheral vascular disorder, pulmonary embolus, sudden death, thrombophlebitis, thrombosis, vascular disorder.

Table 6: Study 2: Percent (%) of Patients Experiencing Clinically Relevant Adverse Events in Combination Therapiesa

Adverse Event Study 2
Irinotecan + 5-FU/LV infusional days 1&2 every 2 weeks
N= 145
5-FU/LV infusional days 1&2 every 2 weeks
N=143
Grades 1-4 Grades 3&4 Grades 1-4 Grades 3&4
TOTAL Adverse Events 100 72.4 100 39.2
GASTROINTESTINAL
  Diarrhea 72.4 14.4 44.8 6.3
    late -- 10.3 -- 4.2
    grade 3 -- 4.1 -- 2.1
    grade 4 28.3 1.4 0.7 0
  Cholinergic syndromeb
  Nausea 66.9 2.1 55.2 3.5
  Abdominal pain 17.2 2.1 16.8 0.7
  Vomiting 44.8 3.5 32.2 2.8
  Anorexia 35.2 2.1 18.9 0.7
  Constipation 30.3 0.7 25.2 1.4
  Mucositis 40 4.1 28.7 2.8
HEMATOLOGIC
  Neutropenia 82.5 46.2 47.9 13.4
    grade 3 -- 36.4 -- 12.7
    grade 4 -- 9.8 -- 0.7
  Leukopenia 81.3 17.4 42 3.5
  Anemia 97.2 2.1 90.9 2.1
  Neutropenic fever -- 3.4 -- 0.7
  Thrombocytopenia 32.6 0 32.2 0
  Neutropenic infection -- 2.1 -- 0
BODY AS A WHOLE
  Asthenia 57.9 9 48.3 4.2
  Pain 64.1 9.7 61.5 8.4
  Fever 22.1 0.7 25.9 0.7
  Infection 35.9 7.6 33.6 3.5
METABOLIC AND NUTRITIONAL
  Bilirubin 19.1 3.5 35.9 10.6
DERMATOLOGIC
  Hand and foot syndrome 10.3 0.7 12.6 0.7
  Cutaneous signs 17.2 0.7 20.3 0
  Alopeciac 56.6 -- 16.8 --
RESPIRATORY
  Dyspnea 9.7 1.4 4.9 0
CARDIOVASCULAR
  Hypotension 3.4 1.4 0.7 0
  Thromboembolic eventsd 11.7 -- 5.6 --
aSeverity of adverse events based on NCI CTC (version 1.0)
bIncludes rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, abdominal cramping or diarrhea (occurring during or shortly after infusion of irinotecan)
cComplete hair loss = Grade 2
dIncludes angina pectoris, arterial thrombosis, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, embolus lower extremity, heart arrest, myocardial infarct, myocardial ischemia, peripheral vascular disorder, pulmonary embolus, sudden death, thrombophlebitis, thrombosis, vascular disorder.

Second-Line Single-Agent Therapy

Weekly Dosage Schedule

In three clinical studies evaluating the weekly dosage schedule, 304 patients with metastatic carcinoma of the colon or rectum that had recurred or progressed following 5-FU-based therapy were treated with CAMPTOSAR. Seventeen of the patients died within 30 days of the administration of CAMPTOSAR; in five cases (1.6%, 5/304), the deaths were potentially drug-related. One of the patients died of neutropenic sepsis without fever. Neutropenic fever occurred in nine (3.0%) other patients; these patients recovered with supportive care.

One hundred nineteen (39.1%) of the 304 patients were hospitalized because of adverse events; 81 (26.6%) patients were hospitalized for events judged to be related to administration of CAMPTOSAR. The primary reasons for drug-related hospitalization were diarrhea, with or without nausea and/or vomiting (18.4%); neutropenia/leukopenia, with or without diarrhea and/or fever (8.2%); and nausea and/or vomiting (4.9%).

The first dose of at least one cycle of CAMPTOSAR was reduced for 67% of patients who began the studies at the 125-mg/m² starting dose. Within-cycle dose reductions were required for 32% of the cycles initiated at the 125-mg/m² dose level. The most common reasons for dose reduction were late diarrhea, neutropenia, and leukopenia. Thirteen (4.3%) patients discontinued treatment with CAMPTOSAR because of adverse events. The adverse events in Table 7 are based on the experience of the 304 patients enrolled in the three studies described in CLINICAL STUDIES (14.1).

Table 7: Adverse Events Occurring in > 10% of 304 Previously Treated Patients with Metastatic Carcinoma of the Colon or Rectuma

Body System & Event % of Patients Reporting
NCI Grades 1-4 NCI Grades 3 & 4
GASTROINTESTINAL
  Diarrhea (late)b 88 31
  7-9 stools/day (grade 3) - (16)
   ≥ 10 stools/day (grade 4) - (14)
  Nausea 86 17
  Vomiting 67 12
  Anorexia 55 6
  Diarrhea (early)c 51 8
  Constipation 30 2
  Flatulence 12 0
  Stomatitis 12 1
  Dyspepsia 10 0
HEMATOLOGIC
  Leukopenia 63 28
  Anemia 60 7
  Neutropenia 54 26
   500 to < 1000/mm³ (grade 3) - (15)
   <500/mm³ (grade 4) - (12)
BODY AS A WHOLE
  Asthenia 76 12
  Abdominal cramping/pain 57 16
  Fever 45 1
  Pain 24 2
  Headache 17 1
  Back pain 14 2
  Chills 14 0
  Minor infectiond 14 0
  Edema 10 1
  Abdominal enlargement 10 0
METABOLIC AND NUTRITIONAL
  ↓Body weight 30 1
  Dehydration 15 4
  ↑ Alkaline phosphatase 13 4
  ↑ SGOT 10 1
DERMATOLOGIC
  Alopecia 60 NAe
  Sweating 16 0
  Rash 13 1
RESPIRATORY
  Dyspnea 22 4
  ↑ Coughing 17 0
  Rhinitis 16 0
NEUROLOGIC
  Insomnia 19 0
  Dizziness 15 0
CARDIOVASCULAR
  Vasodilation (flushing) 11 0
aSeverity of adverse events based on NCI CTC (version 1.0)
bOccurring > 24 hours after administration of CAMPTOSAR
cOccurring ≤ 24 hours after administration of CAMPTOSAR
dPrimarily upper respiratory infections
eNot applicable; complete hair loss = NCI grade 2

Once-Every-3-Week Dosage Schedule

A total of 535 patients with metastatic colorectal cancer whose disease had recurred or progressed following prior 5-FU therapy participated in the two phase 3 studies: 316 received irinotecan, 129 received 5-FU, and 90 received best supportive care. Eleven (3.5%) patients treated with irinotecan died within 30 days of treatment. In three cases (1%, 3/316), the deaths were potentially related to irinotecan treatment and were attributed to neutropenic infection, grade 4 diarrhea, and asthenia, respectively. One (0.8%, 1/129) patient treated with 5-FU died within 30 days of treatment; this death was attributed to grade 4 diarrhea.

Hospitalizations due to serious adverse events occurred at least once in 60% (188/316) of patients who received irinotecan, 63% (57/90) who received best supportive care, and 39% (50/129) who received 5-FU-based therapy. Eight percent of patients treated with irinotecan and 7% treated with 5-FU-based therapy discontinued treatment due to adverse events.

Of the 316 patients treated with irinotecan, the most clinically significant adverse events (all grades, 1-4) were diarrhea (84%), alopecia (72%), nausea (70%), vomiting (62%), cholinergic symptoms (47%), and neutropenia (30%). Table 8 lists the grade 3 and 4 adverse events reported in the patients enrolled to all treatment arms of the two studies described in Clinical Studies.

Table 8: Percent Of Patients Experiencing Grade 3 & 4 Adverse Events In Comparative Studies Of Once-Every-3-Week Irinotecan Therapya

Adverse Event Study 1 Study 2
Irinotecan
N=189
BSCb
N=90
Irinotecan
N=127
5-FU
N=129
TOTAL Grade 3/4 Adverse Events 79 67 69 54
GASTROINTESTINAL
  Diarrhea 22 6 22 11
  Vomiting 14 8 14 5
  Nausea 14 3 11 4
  Abdominal pain 14 16 9 8
  Constipation 10 8 8 6
  Anorexia   5 7 6 4
  Mucositis 2 1 2 5
HEMATOLOGIC
  Leukopenia/Neutropenia 22 0 14 2
  Anemia 7 6 6 3
  Hemorrhage 5 3 1 3
  Thrombocytopenia 1 0 4 2
Infection
  without grade 3/4 8 3 1 4
  neutropenia with grade 3/4 neutropenia 1 0 2 0
Fever
  without grade 3/4 2 1 2 0
  neutropenia with grade 3/4 neutropenia 2 0 4 2
BODY AS A WHOLE
  Pain 19 22 17 13
  Asthenia 15 19 13 12
METABOLIC AND NUTRITIONAL
  Hepaticc 9 7 9 6
DERMATOLOGIC
  Hand and foot syndrome 0 0 0 5
  Cutaneous signsd 2 0 1 3
RESPIRATORYe 10 8 5 7
NEUROLOGICf 12 13 9 4
CARDIOVASCULARg 9 3 4 2
OTHERh 32 28 12 14
aSeverity of adverse events based on NCI CTC (version 1.0)
bBSC = best supportive care
cHepatic includes events such as ascites and jaundice
dCutaneous signs include events such as rash
eRespiratory includes events such as dyspnea and cough
fNeurologic includes events such as somnolence
gCardiovascular includes events such as dysrhythmias, ischemia, and mechanical cardiac dysfunction
hOther includes events such as accidental injury, hepatomegaly, syncope, vertigo, and weight loss

The incidence of akathisia in clinical trials of the weekly dosage schedule was greater (8.5%, 4/47 patients) when prochlorperazine was administered on the same day as CAMPTOSAR than when these drugs were given on separate days (1.3%, 1/80 patients). The 8.5% incidence of akathisia, however, is within the range reported for use of prochlorperazine when given as a premedication for other chemotherapies.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of CAMPTOSAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Myocardial ischemic events have been observed following irinotecan therapy. Thromboembolic events have been observed in patients receiving CAMPTOSAR.

Symptomatic pancreatitis, asymptomatic pancreatic enzyme elevation have been reported. Increases in serum levels of transaminases (i.e., AST and ALT) in the absence of progressive liver metastasis have been observed.

Hyponatremia, mostly with diarrhea and vomiting, has been reported.

Transient dysarthria has been reported in patients treated with CAMPTOSAR; in some cases, the event was attributed to the cholinergic syndrome observed during or shortly after infusion of irinotecan.

Interaction between irinotecan and neuromuscular blocking agents cannot be ruled out. Irinotecan has anticholinesterase activity, which may prolong the neuromuscular blocking effects of suxamethonium and the neuromuscular blockade of non-depolarizing drugs may be antagonized.

Read the entire FDA prescribing information for Camptosar Inj (Irinotecan Hydrochloride) »

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Camptosar Injection - User Reviews

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