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CM

CMV immunoglobulin (CytoGam)

✓ Approved

Sanofi S.A · Polyclonal Antibodies · Polyclonal Antibodies

What is CMV immunoglobulin?

CMV immunoglobulin is a polyclonal antibodies developed by Sanofi S.A. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesCytoGam
CompanySanofi S.A
Drug ClassPolyclonal Antibodies, Antibody
RouteInjectable (Others), Intravenous (IV)
StatusApproved

Therapeutic Indications

CMV immunoglobulin is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Surgical and medical proceduresAntiviral prophylaxis✓ Approved

Related Research Articles

PubMedPain medicine (Malden, Mass.)2026-11-11

Association Between Cytomegalovirus and Fibromyalgia: A Large-Scale Retrospective Case-Control Study.

Nissan Johnatan J, Melcer Karin K, Fennig Uriel U, Loebenstein Roni R et al.

Fibromyalgia is a chronic widespread pain disorder with incompletely understood pathogenesis. Viral infections have been proposed as potential triggers, but studies examining cytomegalovirus (CMV), a herpesvirus establishing lifelong latency, and fibromyalgia are scarce. We investigated the association between CMV infection and subsequent fibromyalgia. This retrospective matched case-control study used a database of over 370,000 individuals from 01/2003 to 12/2025. Cases were defined by at least two fibromyalgia diagnoses separated by ≥ 6 months. Up to five controls per case were matched on year of birth, sex, lookback period, and neighborhood socioeconomic status. Exposure was defined as a positive CMV IgM or IgG test, with a two-year washout period. Conditional logistic regression estimated odds ratios adjusted for psychiatric disorders, sleep disorders, obesity, and smoking. After exclusions, 1,811 cases were matched to 8,988 controls. Prior CMV exposure was documented in 50.7% of cases versus 45.6% of controls (P < 0.001). CMV infection was significantly associated with fibromyalgia (adjusted odds ratio 1.321; 95% CI 1.173-1.488; P < 0.001). The association persisted across stricter case definitions and alternative washout periods. CMV infection is significantly associated with increased odds of fibromyalgia. Prospective studies are warranted to establish causality and underlying mechanisms.

PubMedMedicine2026-11-11

Syphilitic proctitis with profuse rectal bleeding in an HIV-infected patient with preserved CD4 count (case report).

Mosi Mohamad H MH, Alfarra Hisham H, Davi Chandni C, Saaki Shaila S et al.

Syphilitic proctitis is an uncommon and frequently under-recognized manifestation of Treponema pallidum infection that can closely mimic inflammatory, infectious, or neoplastic rectal disease. We report an unusually severe, hemorrhagic presentation in a patient with human immunodeficiency virus (HIV) and a preserved cluster of differentiation 4 (CD4) count, a setting in which overlapping etiologies often delay the diagnosis. A heterosexual man in his early 50s with untreated HIV infection and chronic hepatitis B-related cirrhosis (Child-Pugh class B) presented with sudden onset of profuse hematochezia, watery diarrhea, abdominal cramping, and fatigue. Computed tomography angiography revealed pronounced rectal wall thickening with deep ulceration. Colonoscopy demonstrated an indurated, ulcerated rectal lesion, and biopsy showed dense lymphoplasmacytic inflammation, with spirochetes confirmed by T pallidum immunohistochemistry. Negative cytomegalovirus (CMV) immunohistochemistry, undetectable CMV DNA in plasma and rectal tissue, and a preserved CD4 count (445 cells/µL) made CMV proctitis unlikely. The overall clinical, endoscopic, and histologic findings supported a diagnosis of syphilitic proctitis. Management included doxycycline 100 mg twice daily for 2 weeks, selected because of the patient's documented penicillin allergy. Antiretroviral therapy with bictegravir/tenofovir alafenamide/emtricitabine was initiated to treat HIV and provide concurrent hepatitis B coverage. Within 2 weeks, the patient experienced complete resolution of hematochezia and diarrhea. At 3-month follow-up, the CD4 count had risen to 570 cells/µL, HIV RNA was undetectable (<20 copies/mL), and the rapid plasma reagin titer had declined from 1:512 to 1:32. This case underscores that syphilitic proctitis may manifest with severe ulcerative disease even in patients with relatively preserved immune function. Clinicians should maintain vigilance for syphilis in individuals with HIV who present with rectal bleeding or proctitis to prevent diagnostic delays and ensure timely therapy.

PubMedCureus2026-11-11

Intestinal Paracoccidioidomycosis Masquerading as Crohn's Disease: Diagnostic Pitfalls in a Case Report.

Cerqueira Ana A, Seco Tiago T, Moniz Joana J, Lemos Bárbara B et al.

Paracoccidioidomycosis (PCM) is a systemic fungal infection caused by Paracoccidioides spp., predominantly found in Brazil. It primarily affects the respiratory system, while extrapulmonary involvement is rare. Disseminated PCM in immunocompetent hosts may be associated with exposure burden, host factors, delayed diagnosis, and disease phenotype. We present the case of a 28-year-old Brazilian man who had been living in Portugal for five months and presented to the emergency department with persistent abdominal pain lasting three weeks. Initial evaluation revealed mesenteric lymph-node conglomerates. During hospitalization, an extensive workup was performed, including screening for active neoplastic disease, immunosuppressive states, and active infection. A fourth-generation HIV combined antigen/antibody test was negative. Immunoglobulin levels were within the normal range (immunoglobulin A 160 mg/dL, immunoglobulin M 200 mg/dL and immunoglobulin G 1500 mg/dL). There was no history of immunosuppressive medication use including steroid or biologic, and no history of diabetes or transplantation. There was also no clinical or imaging evidence of solid or haematological malignancy. Immunophenotyping of peripheral blood and two lymph nodes showed no changes of pathological significance. Clinical, imaging, endoscopic, and histologic findings suggested Crohn's disease, although the presentation was atypical because of the extent of painful lymphadenopathy and hepatosplenomegaly. However, Periodic Acid-Schiff (PAS) and Ziehl-Neelsen staining were performed on the initial slides containing granulomas (inguinal lymph node and samples from the ileum and colon, but did not demonstrate evidence of infection at that time). A trial with high-dose corticosteroids was initiated.  Following subsequent deterioration, an axillary lymph-node was excised. Gomori-Grocott (GG) staining, which was only performed at this stage, revealed the "ship's pilot wheel" appearance. There was no isolation in cultures and serologic and polymerase chain reaction (PCR) testing for Paracoccidioides spp. could not be performed at our hospital. Therefore, the diagnosis of paracoccidioidomycosis was established based on histologic morphology, epidemiologic context, and suggestive clinical features. After the diagnosis was established, the initial slides were reviewed and GG staining was added, becoming clear that the fungal forms were already present in all the tested samples, but had gone unrecognized. Imported fungal infections in non-endemic areas present significant clinical challenges, including delayed diagnosis and limited clinician experience. In Portugal, only one private laboratory can perform PCR and serologic testing for paracoccidioidomycosis. This limitation highlights an important lesson from this case: a diagnosis cannot be made if the disease is not considered. This case may therefore serve as a useful resource for settings with similar diagnostic limitations. Given the extreme rarity of extrapulmonary PCM, this case highlights the need for a comprehensive diagnostic approach to intestinal granulomatous diseases, particularly in patients from endemic regions, and emphasizes the role of internal medicine in this diagnostic process.

PubMedJPGN reports2026-11-11

A real-world comparison of celiac tissue transglutaminase immunoglobulin A antibody levels in pediatric patients using two different diagnostic kits.

Kori Michal M, Guz-Mark Anat A, Perets Tsachi Tsadok TT, Davidpur Amit A et al.

Pediatric celiac disease (CeD) may be diagnosed without a biopsy when tissue-transglutaminase (TTG) immunoglobulin A (IgA) antibodies are ≥10x the upper limit of normal (ULN) and anti-endomysial antibodies are positive in a second sample. The no-biopsy diagnosis demands a very high accuracy and reliability of the TTG diagnostic kits. Inter-assay differences may affect category classification. We compared TTG-IgA levels performed by two reliable kits: Bioplex 2200 and Liaison-XL in routine care. Using the Clalit Health Services database, we identified pediatric patients with paired TTG-IgA measurements from both kits within ≤14 days. Values were expressed as multiples of ULN and categorized: 10x ULN. Agreement was assessed for ≤7 and ≤14-day windows using Cohen's ĸ. Category discordance occurred in 17.4% (109/625) of paired tests within 14 days and 11.8% (38/321) within 7 days. Overall agreement was substantial (ĸ = 0.62 for 14 days; ĸ = 0.63 for 7 days). Concordance was high for negative results (96.0%), but significantly lower for the critical >10x ULN threshold at 14 days (88.2%, p = 0.009). Significant discordance between these two reliable TTG-IgA kits at 14 days, exceeding 10% in the >10x ULN category, warrants careful consideration when using the no-biopsy approach for CeD diagnosis, as assay choice may impact clinical classification.

PubMedFrontiers in pediatrics2026-11-11

Characteristics of hospitalized children with immunoglobulin A vasculitis: a 7-year retrospective study of 119,217 pediatric inpatients in China.

Ma Yue Y, Wang Xinyu X, Zhang Ningning N, Liu Chang C et al.

Immunoglobulin A vasculitis (IgAV), formerly Henoch-Schonlein purpura (HSP), is the most common systemic vasculitis in children. This study aimed to systematically analyze the demographic, epidemiological, clinical, and infectious characteristics of pediatric IgAV using a large-scale real-world dataset. A retrospective study was conducted using inpatient discharge abstracts from Beijing Children's Hospital, Capital Medical University, spanning January 2016 to December 2022. A total of 119,217 pediatric patients (aged 18 years or younger) diagnosed with IgAV were enrolled. Demographic characteristics, clinical classification, infectious triggers, pathogen spectrum, and multisystem comorbidities and complications were systematically analyzed. Statistical analyses were performed using SPSS 26.0. A two-sided P < 0.05 was considered statistically significant. Among 119,217 enrolled patients, the mean age was 7.79 ± 3.17 years with a male-to-female ratio of 1.30:1. School-aged children (50.77%) and Han ethnicity (93.27%) predominated. Southern China (57.91%) and rural areas (56.91%) showed higher case volumes (both P < 0.001). The winter-spring period (November-March) concentrated 50.66% of cases (P < 0.001). Clinically, unspecified type was most common (57.02%), followed by renal type (20.04%). Renal-type cases showed a significant increasing trend (P < 0.001). Co-infections were present in 47.49% of patients. Mycoplasma pneumoniae was the most frequently recorded pathogen (5.82%), compared with Streptococcus pneumoniae (0.32%). Digestive system complications were most prevalent (4.97%). Pediatric IgAV in this large Chinese inpatient cohort demonstrated male predominance, a winter-spring peak, and an increasing proportion of renal-type classification (from 15.5% to 27.0% over 7 years). Mycoplasma pneumoniae was the most frequently recorded pathogen (5.82%). These findings suggest that systematic multi-pathogen screening (including Mycoplasma pneumoniae) and standardized long-term urinalysis follow-up may be warranted in the management of hospitalized pediatric IgAV patients.

PubMedJournal of the science of food and agriculture2026-11-11

Whey protein hydrolysate alleviates ovalbumin-induced allergic responses in Brown Norway rats: associations with immunoglobulin E-related responses and the gut microbiota-short-chain fatty acid axis.

Wang Yi Y, Wang Xinze X, Chen Liang L, Zhang Xinxue X et al.

Whey protein hydrolysate (WPH) has considerable potential as a functional food ingredient; however, its role in alleviating allergic responses and the underlying mechanisms remain insufficiently understood, particularly the potential role of gut microbiota and their metabolites. This study characterized the structural changes of WPH following enzymatic hydrolysis, evaluated its effects on allergic responses in an ovalbumin-induced allergic rat model, and investigated the associated changes in gut microbiota and short-chain fatty acids (SCFAs) to explore their potential involvement in the antiallergic effects of WPH. Whey protein hydrolysate was prepared by two-step enzymatic hydrolysis. Compared with whey protein isolate (WPI), the amide I band shifted from 1651.85 to 1654.62 cm-1, and the α-helix content decreased from 34.67% to 23.23%, with increases in β-sheet (10.69% to 15.66%), β-turn (11.03% to 12.63%), and random coil (43.61% to 48.40%), indicating a more flexible conformation. Whey protein hydrolysate inhibited hyaluronidase concentration-dependently, reaching 70% inhibition at 60 g L-1. In an ovalbumin (OVA)-induced allergy model in Brown Norway (BN) rats, WPH was administered orally at 200, 500, and 1000 mg kg-1 day-1 for 42 days. Whey protein hydrolysate attenuated hypothermia and reduced serum immunoglobulin E (IgE), OVA-specific IgE (sIgE), histamine, and β-hexosaminidase levels, while ameliorating jejunal damage and mast cell degranulation (P < 0.05). WPH also increased the Richness, ACE, and Chao1 indices (P < 0.05). Whey protein hydrolysate alleviated allergic responses by attenuating systemic allergic responses, reducing mast-cell activation and allergic mediator release, and partially restoring gut microbial richness and diversity, supporting its potential as a functional food ingredient. © 2026 Society of Chemical Industry.

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