Doribax

Doribax (doripenem) is an antibiotic used to treat severe infections of the stomach, bladder, or kidneys. Common side effects of Doribax include:

• injection site reactions (pain, redness, swelling),
• nausea,
• headache,
• diarrhea,
• vaginal itching or discharge, or
• rash.

Tell your doctor if you have serious side effects of Doribax including:

• unusual tiredness, or
• pale skin.

The recommended dosage of Doribax is 500 mg administered every 8 hours by intravenous infusion over one hour in patients 18 years of age and older. Doribax may interact with valproic acid or probenecid. Other drugs may interact with Doribax. Tell your doctor all medications and supplements you use. During pregnancy, Doribax should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

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

 

Doribax Consumer Information

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

Call your doctor at once if you have:

• severe stomach pain;
• diarrhea that is watery or bloody; or
• severe itching or skin rash.

Common side effects may include:

• headache;
• diarrhea, nausea;
• vaginal itching or discharge;
• mild rash; or
• pain, swelling, or redness where the medicine was injected.

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 Doribax (Doripenem for Injection)

 

Doribax Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of labeling:

• Anaphylaxis and serious hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]
• Interaction with sodium valproate [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]
• Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]
• Development of drug-resistant bacteria [see WARNINGS AND PRECAUTIONS]
• Pneumonitis with inhalational use [see WARNINGS AND PRECAUTIONS]

Adverse Reactions From Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice.

During clinical investigations, 1338 adult patients were treated with DORIBAX® (1076 patients received doripenem 500 mg administered over 1 hour every 8 hours and 262 patients received doripenem 500 mg administered over 4 hours every 8 hours); in some patients parenteral therapy was followed by a switch to an oral antimicrobial. [see Clinical Studies]. The median age of patients treated with DORIBAX® was 54 years (range 18– 90) in the comparative complicated urinary tract infections (cUTI) study, 46 years (range 18–94) in the pooled comparative complicated intra-abdominal infections (cIAI) studies, and 56 years (range 18-94) in the other Phase 3 trials. There was a female predominance (62%) in the comparative cUTI study and a male predominance (63% and 75%) in the comparative cIAI and other Phase 3 trials, respectively. The patients treated with DORIBAX® were predominantly Caucasian (79%) in the five comparator-controlled Phase 3 studies.

The most common adverse drug reactions ( ≥ 5%) observed in the five DORIBAX® comparator-controlled Phase 3 clinical trials were anemia, headache, nausea, diarrhea, rash, phlebitis, and elevated hepatic enzymes. During clinical trials, adverse events led to discontinuation of DORIBAX® in 4.1% (55 of 1338) of patients compared to 4.3% (58 of 1325) of comparator-treated patients.

Adverse reactions due to DORIBAX® 500 mg every 8 hours that occurred at a rate ≥ 1 % are listed in Table 4. Hypersensitivity reactions related to intravenous study drug occurred at a rate of less than 1%.

Table 4: Adverse Reactions with Incidence Rates (%) of ≥ 1% in the Controlled Phase 3 Clinical Trials

System organ class	Complicated Urinary Tract Infections (one trial)		Complicated Intra Abdominal Infections (two trials)		Other Phase 3 Trials (two trials)
	DORIBAX® 500 mg administered every 8 hours (n =376 )	Levofloxacin 250 mg administered IV every 24 hours (n = 372)	DORIBAX® 500 mg administered every 8 hours (n = 477)	Meropenem 1 g administered every 8 hours (n = 469)	DORIBAX® 500 mg administered every 8 hours (n =485 )	Comparator* (n=484)
Nervous system disorders
Headache	16	15	4	5	3	3
Vascular disorders
Phlebitis	4	4	8	6	2	1
Gastro-intestinal disorders
Nausea	4	6	12	9	7	7
Diarrhea	6	10	11	11	12	14
C. difficile colitis	< 1	0	< 1	0	1	2
Blood and Lymphatic System Disorders
Anemia	2	1	10	5	5	6 8
Skin and subcutaneous disorders
Pruritus	1	1	3	2	1	1
Rash	1	1	4	2	6	5
Investigations
Hepatic Enzyme elevation**	2	4	2	4	7	6
Infections and Infestations
Oral candidiasis	1	0	1	2	3	1
Vulvomycotic infection	2	1	1	< 1	0	< 1
* Comparators include piperacillin/tazobactam (4.5 g every 8 hours) and imipenem (500 mg every 6 hours or 1 g every 8 hours) ** including preferred terms (alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, and transaminases increased) and laboratory test values (ALT or AST ≤ ULN at baseline and > 5 x ULN at End of Treatment (EOT))

In a Phase 1 study of healthy subjects receiving doripenem doses greater than the approved dose of 500 mg every 8 hours for 10 to 14 days, the incidence of rash was higher than that observed in subjects who received 500 mg every 8 hours. The rash resolved within 10 days after doripenem administration was discontinued.

Postmarketing Experience

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

Hematologic: Leukopenia, Neutropenia, Thrombocytopenia

Immune System: Anaphylaxis

Nervous System: Seizure

Renal: Renal impairment/failure

Respiratory: Interstitial pneumonia

Skin: Toxic epidermal necrolysis, Stevens-Johnson Syndrome

Read the entire FDA prescribing information for Doribax (Doripenem for Injection)